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8
 Κλινικό Θέμα




                                                                                    Κλινικό Θέμα

                                         Άλγος Δεξιού Υποχονδρίου και
                                       Φυσιολογικό Υπερηχοτομογράφημα
                                                                    Ελεύθερη μετάφραση και επιμέλεια: Κων/νος Ι. Ζωγράφος
                     Κλινικό σενάριο                                           ντικός, όπως και στις υπόλοιπες λειτουργικές διαταραχές
                                                                               του πεπτικού συστήματος.
                     Γυναίκα 30 ετών προσέρχεται στο ιατρείο σας αναφέ-
                     ροντας από έτους, διαλείπον, διαξιφιστικό άλγος δεξιού
                                                                               Η συμπτωματολογία
                     υποχονδρίου, με ταυτόχρονη εμφάνιση ναυτίας και ενίο-
                     τε εμέτου. Η διάρκεια του πόνου ποικίλει από 30΄ έως 2    Προεξέχον σύμπτωμα στη δυσκινησία των χοληφόρων εί-
                     ώρες, αντανακλά στη δεξιά ωμική άρθρωση και δε συνδέ-     ναι το εντοπισμένο άλγος στο δεξιό υποχόνδριο. Τα χα-
                     εται με τις κενώσεις ή τη φυσική άσκηση. Σε επανειλημ-    ρακτηριστικά του έχουν καθοριστεί από τα κριτήρια Ρώ-
                     μένες επισκέψεις της ασθενούς στα επείγοντα περιστατι-    μης ΙΙΙ. Ο πόνος είναι διαλείπων, αντανακλά στη δεξιά ωμι-
                     κά, ο αιματολογικός έλεγχος (ηπατική βιοχημεία, αμυλά-    κή άρθρωση ή την πλάτη, συχνά συνοδεύεται από ναυτία
                     ση κ.λπ.) καθώς και το υπερηχοτομογράφημα άνω κοιλί-      ή έμετο και συνήθως είναι μεταγευματικός.
                     ας ήταν φυσιολογικά. Πρόσφατη ενδοσκόπηση ανωτέρου        Ίκτερος ή πυρετός δεν υπάρχουν και η κλινική εξέταση εί-
                     πεπτικού δεν ανέδειξε παθολογία.                          ναι συνήθως χωρίς ευρήματα εκτός από κάποια ήπια ευαι-
                                                                               σθησία κατά την ψηλάφηση του δεξιού υποχονδρίου.
                     Το πρόβλημα
                     Φυσιολογικό υπερηχοτομογράφημα και αιματολογικός          Διαγνωστική προσπέλαση
                     έλεγχος. Προέρχεται το άλγος από τα χοληφόρα; Ίσως        Διαγνωστικά εργαλεία πρώτης γραμμής, η γαστροσκόπη-
                     πρόκειται για αλιθιασική χολοκυστοπάθεια αφού αποκλει-    ση, η MRCP, και το EUS με τη γνωστή ειδικότητα και ευαι-
                     σθούν πρώτα το πεπτικό έλκος, η χοληδοχολιθίαση και       σθησία που τα διακρίνει.
                     μικρολιθίαση, οι νεοπλασίες χοληφόρων και παγκρέατος,
                                                                               Στο πρόσφατο παρελθόν μια σειρά δοκιμασιών μάς έδι-
                     το ευερέθιστο έντερο και το μυοσκελετικό άλγος.
                                                                               νε τη δυνατότητα εκτίμησης της συσπαστικής λειτουργί-
                     Η παθοφυσιολογία της αλιθιασικής χολοκυστοπάθειας         ας της χοληδόχου κύστεως. Όπως η αναπαραγωγή πόνου
                     δεν είναι πλήρως κατανοητή. Πιθανές θεωρίες είναι η πα-   μετά από χορήγηση CCK, η χολοκυστογραφία με CCK, η
                     ρεμπόδιση στη ροή της χολής από τη χοληδόχο κύστη, δι-    διενέργεια υπερηχοτομογραφήματος, και η μέτρηση του
                     αταραχές κινητικότητας αυτής, έλλειψη συντονισμού με-     όγκου της χοληδόχου με παράλληλη χορήγηση CCK ή
                     ταξύ χοληδόχου κύστεως και σφιγκτήρα του Οddi και, τέ-    γεύματος. Παρόλα αυτά, η άμεση εξάρτηση του αποτε-
                     λος, η σπλαγχνική υπερευαισθησία.                         λέσματος από τον εκτελούντα την εξέταση, καθώς και η
                     Διαταραχή κινητικότητας της χοληδόχου παρατηρείται        χαμηλή ευαισθησία και ειδικότητα που διαθέτουν τις καθι-
                     μετά από εναπόθεση κρυστάλλων χοληστερόλης επί του        στούν πλέον μη αξιόπιστες.
                     τοιχώματός της, ασθενής ανταπόκριση στη χολοκυστοκι-      Η πλέον χρησιμοποιούμενη δοκιμασία για τη διάγνωση της
                     νίνη (CCK) και, τέλος, συγγενείς ανωμαλίες αυτής. Ο ρό-   αλιθιασικής χολοκυστοπάθειας είναι το σπινθηρογράφη-
                     λος της σπλαγχνικής υπερευαισθησίας είναι εξίσου σημα-    μα χοληφόρων (99mtechnetium- labeled hepatoiminodiacetic




endo_no12 c.indd 8                                                                                                                      13/5/2009 3:30:07 µµ
9


                     acid, 99mHIDA). Το iminodiacetic acid προσλαμβάνεται από Ίσως η πιο αξιόπιστη διαδικασία είναι εκείνη την οποία πε-
                     το ήπαρ και απεκκρίνεται με τη χολή. Το κλάσμα εξώθησης ριγράφουν οι Krishnamurthy και συνεργάτες, κατά τους
                     της χοληδόχου κύστης εκτιμάται μετά από χορήγηση CCK, οποίους η χορήγηση είναι 3΄ σε διάστημα 30΄και 60΄.
                     ενώ ο βαθμός κένωσης εξαρτάται από τη δόση και το ρυθ- Η απουσία, λοιπόν, προτύπου τρόπου εκτέλεσης της δο-
                     μό χορήγησης. Χαμηλό κλάσμα εξώθησης είναι ενδεικτικό κιμασίας έχει σαν αποτέλεσμα τη μη κοινά αποδεκτή και
                     δυσλειτουργίας. Ορισμένοι ασθενείς εμφανίζουν αναπαρα- ίσως τη λανθασμένη αξιολόγηση του αποτελέσματος. Οι




                                                                                                                                                       Κλινικό Θέμα
                     γωγή των συμπτωμάτων κατά τη διάρκεια της δοκιμασίας, περισσότερες δημοσιεύσεις για την εκτίμηση των αποτε-
                     και αυτό αποτελεί προγνωστικό στοιχείο για καλή ανταπό- λεσμάτων αναφέρουν παρουσία δυσλειτουργίας όταν το
                     κριση στην πιθανή χολοκυστεκτομή. Όταν η HIDA επιβε- κλάσμα εξώθησης της χοληδόχου είναι <35-40%. Επίσης
                     βαιώσει τη δυσλειτουργία της χοληδόχου η χειρουργική υπερσυσταλτικότητα της χοληδόχου (>85%) μπορεί να
                     αντιμετώπιση είναι πολύ πιθανή. Εκτιμάται, ότι τις δύο τε- προκαλέσει αναπαραγωγή παρόμοιων συμπτωμάτων.
                     λευταίες δεκαετίες η αύξηση του αριθμού των χολοκυστε-
                     κτομών ίσως οφείλεται στις αυξανόμε-                       Η ειδικότητα της χολοκυστογραφίας για τη διάγνωση της
                     νες θετικές δοκιμασίες. Αρκετές μελέ-                                         δυσλειτουργίας της χοληδόχου δεν εί-
                     τες προσπάθησαν να αναδείξουν τα                                              ναι 100%. Αρκετές άλλες νοσολογικές
                     πιθανά οφέλη μιας τέτοιας απόφασης         Παρά την ευρεία χρήση              οντότητες όπως η παχυσαρκία, ο σακ-
                     εκ μέρους του θεράποντος ιατρού,           της χολοκυστογραφίας               χαρώδης διαβήτης, η κύηση, η κοιλιο-
                     αλλά η αναδρομικότητα των μελετών                                             κάκη, καθώς και λήψη φαρμάκων (ανα-
                                                                     για τη διάγνωση               στολείς διαύλων ασβεστίου, οπιοειδή,
                     καθώς και ο μικρός αριθμός των συμ-
                     μετεχόντων ασθενών καθιστά τα απο-               της αλιθιασικής              αντιχολινεργικά) μπορούν να προκαλέ-
                     τελέσματά τους χαμηλής αξιοπιστί-             χολοκυστοπάθειας                σουν παρόμοια εικόνα.
                     ας. Όμως μια προοπτική μελέτη των             υπάρχουν αρκετά
                     Yap et al ξεκάθαρα υποστηρίζει τη χει-                                     ΜΕΤΑ ΤΗ
                     ρουργική αντιμετώπιση του προβλή-           αδιευκρίνιστα σημεία           ΧΟΛΟΚΥΣΤΕΚΤΟΜΗ…
                     ματος. Ασθενείς με θετική HIDA για            για τη διαδικασία            Παρά την ΄΄θετικά προσκείμενη΄΄ βι-
                     αλιθιασική χολοκυστοπάθεια (κλάσμα               εκτέλεσης της             βλιογραφία ως προς τη θεραπευτι-
                     εξώθησης < 40%) διακρίθηκαν σε δυο                                         κή αποτελεσματικότητα της χολοκυ-
                     υποομάδες, χειρουργηθέντες (n =11)          δοκιμασίας τα οποία            στεκτομής, υπάρχουν ακόμη αρκετά
                     και μη (n = 10). Χρόνος παρακολού-               μειώνουν την              αναπάντητα ερωτήματα. Οι ασθενείς
                     θησης 34 μήνες. Από την πρώτη ομά-               αξιοπιστία της            με δυσλειτουργία της χοληδόχου
                     δα 10 είχαν πλήρη ύφεση συμπτωμά-                                          έχουν μερική και όχι πλήρη ύφεση
                     των, και 1 μερική^ εν αντιθέσει, όλοι οι                                   των συμπτωμάτων μετά το χειρουρ-
                     ασθενείς της δεύτερης ομάδας παρέ-                                         γείο. Οι λόγοι παραμένουν αδιευκρί-
                     μειναν συμπτωματικοί, και 2 χειρουργήθηκαν.              νιστοι, αλλά πιθανότατα να υπάρχει άλλη γενεσιουρ-
                     Οι Ponsky και συνεργάτες σε μια μετα-ανάλυση 5 μελε- γός αιτία ή η δυσλειτουργία της χοληδόχου να αποτε-
                     τών που αφορούσαν 274 ασθενείς με αλιθιασική χολοκυ- λεί στοιχείο ενός πολυπαραγοντικού συνδρόμου. Υπάρ-
                     στοπάθεια (θετική HIDA) αξιολόγησαν τα οφέλη της χει- χουν ανέκδοτες αναφορές ασθενών με φυσιολογική δο-
                     ρουργικής θεραπείας. Βελτίωση των συμπτωμάτων εμφά- κιμασία HIDA οι οποίοι είχαν βελτίωση των συμπτωμά-
                     νισε το 98% των χειρουργηθέντων εν αντιθέσει με το 32% των τους μετά τη χολοκυστεκτομή καθώς και αρκετές
                     από την ομάδα εκείνων που αντιμετωπίστηκαν συντηρητι- μελέτες οι οποίες αποκαλύπτουν παρόμοια ανταπόκρι-
                     κά. Πλήρη ύφεση εμφάνισαν το 74% και 8% αντίστοιχα.      ση μετά το χειρουργείο σε ασθενείς με ή χωρίς δυσλει-
                                                                              τουργία της χοληδόχου! Δυστυχώς δεν υπάρχουν ακό-
                     ΑΜΦΙΒΟΛΙΕΣ…                                              μη ασφαλή προγνωστικά στοιχεία πιθανούς ανταπόκρι-
                                                                              σης στη χολοκυστεκτομή ατόμων με επιβεβαιωμένη χο-
                     Παρά την ευρεία χρήση της χολοκυστογραφίας για τη δι-
                                                                              λοκυστοπάθεια. Τέλος, φαίνεται ότι ο βαθμός μείωσης
                     άγνωση της αλιθιασικής χολοκυστοπάθειας υπάρχουν αρ-
                                                                              της συσπαστικής ικανότητας της χοληδόχου, εκτιμώμε-
                     κετά αδιευκρίνιστα σημεία για τη διαδικασία εκτέλεσης
                                                                              νος με τη δοκιμασία HIDA, δε συνδέεται απαραίτητα με
                     της δοκιμασίας τα οποία μειώνουν την αξιοπιστία της. Οι
                                                                              καλύτερη βελτίωση των συμπτωμάτων μετά το χειρουρ-
                     μετρήσεις του κλάσματος εξώθησης της χοληδόχου επη-
                                                                              γείο.
                     ρεάζονται άμεσα από τη δόση, το ρυθμό και τη διάρκεια
                     χορήγησης της CCK. Τυποποιημένος τρόπος διενέργειας Η μακροχρόνια διατήρηση της ανταπόκρισης ίσως είναι
                     της δοκιμασίας, κοινά αποδεκτός, δεν περιγράφεται. Οι ελλιπώς μελετημένη. Το χρονικό διάστημα μελέτης που
                     κατευθυντήριες γραμμές της Εταιρείας Πυρηνικής Ιατρι- αναφέρεται στις περισσότερες μελέτες, συμπεριλαμβα-
                     κής δεν αναφέρουν καμία συγκεκριμένη δόση ή διάρκεια νομένης και του Ponsky, ποικίλει από 9-30 μήνες. Μια
                     χορήγησης της CCK. Στις οδηγίες χρήσης του εμπορικού μελέτη παιδιατρικών ασθενών, με χαμηλό κλάσμα εξώ-
                     προϊόντος Kinevac (sincalide), μια μορφή συνθετικής CCK, θησης, οι οποίοι υποβλήθηκαν σε χολοκυστεκτομή, 1
                     αναφέρονται τρεις διαφορετικοί τρόποι χορήγησης!!! μήνα μετά είχαν υψηλά ποσοστά ανταπόκρισης. Όμως




endo_no12 c.indd 9                                                                                                                         13/5/2009 3:30:08 µµ
μετά από 2ετή παρακολούθηση τα ποσοστά των ασθε-          χου γίνεται βάσει του αποτελέσματος της αναίμακτης
                  νών οι οποίοι παρέμεναν ασυμπτωματικοί ήταν παρόμοια      HIDA. Επομένως, σε ασθενή με ακέραια χοληδόχο, η δι-
                  με εκείνα που αντιμετωπίστηκαν συντηρητικά. Η φυσι-       άγνωση της αλιθιασικής χολοκυστοπάθειας προηγείται
                  κή εξέλιξη της δυσλειτουργίας της χοληδόχου παραμέ-       της ΔΣΟ, θέτοντας έτσι την απόφαση διενέργειας ERCP
                  νει άγνωστη. Παρόλα αυτά σε μια μελέτη αναφέρεται ότι     και παράλληλης μανομετρίας (εξετάσεις υψηλής επικιν-
                  ασθενείς με επιβεβαιωμένη δυσλειτουργία (χαμηλό κλά-      δυνότητας) σε δεύτερο χρόνο. Ακόμη και σε κέντρα ανα-
 Κλινικό Θέμα




                  σμα εξώθησης στη δοκιμασία HIDA), εάν υποβληθούν σε       φοράς, ο κίνδυνος εμφάνισης επιπλοκών (λοιμώξεις, αι-
                  εκ νέου δοκιμασία μετά από μήνες ή χρόνια, η δυσλει-      μορραγία, διάτρηση, παγκρεατίτιδα) με συνοδό νοση-
                  τουργία παραμένει.                                        λεία, μετά από διενέργεια ERCP/ μανομετρίας ανέρχε-
                                                                            ται σε 10-15%. Περιορισμένες αναφορές, αναδρομικού
                  ΔΥΣΛΕΙΤΟΥΡΓΙΑ ΣΦΙΓΚΤΗΡΑ ΤΟΥ ODDI                          υλικού, που αφορούν τα αποτελέσματα σφιγκτηροτομής
                  Η Δυσλειτουργία του Σφιγκτήρα του Οddi (ΔΣΟ) δυνητι-      σε ασθενείς με ΔΣΟ, περιγράφουν ύφεση του άλγους σε
                  κά αποτελεί άλλη μια αιτία εμφάνισης άλγους στην περιο-   ποσοστά 40-70%.
                  χή της άνω κοιλίας. Τυπικά εμφανίζεται μετά από χολοκυ-   Σε ασθενή με φυσιολογικό κλάσμα εξώθησης χοληδόχου
                  στεκτομή, εντοπίζεται στο δεξιό υποχόνδριο, έχοντας συ-   κύστης, μετά από δοκιμασία HIDA, η απόφαση της εμπει-
                  νεχή ή κολικοειδή χαρακτήρα. Αρκετά είναι τα ερωτήματα    ρικής χολοκυστεκτομής ή της ERCP, θα πρέπει να λαμβά-
                  τα οποία παραμένουν αναπάντητα, και αφορούν τη σχέση      νεται μετά από λεπτομερή ενημέρωση του ασθενούς για
                  ΔΣΟ και δυσλειτουργίας της χοληδόχου: (1) εμφανίζεται     τους κινδύνους και τα οφέλη αυτών.
                  η ΔΣΟ σε ασθενείς με άθικτη χοληδόχο κύστη (2) υπάρχει
                  σχέση μεταξύ ΔΣΟ και δυσλειτουργίας της χοληδόχου και     ΔΗΜΟΣΙΕΥΜΕΝΕΣ ΚΑΤΕΥΘΥΝΤΗΡΙΕΣ
                  (3) ποιος είναι ο ρόλος της ΔΣΟ και της λανθάνουσας δυ-   ΓΡΑΜΜΕΣ
                  σλειτουργίας της χοληδόχου, στην αξιολόγηση και το χει-
                                                                            Η διάσκεψη Ρώμης ΙΙΙ περιγράφει και αποσαφηνίζει τα δι-
                  ρισμό ασθενών με άλγος δεξιού υποχονδρίου και φυσιο-
                                                                            αγνωστικά κριτήρια για τις λειτουργικές διαταραχές της
                  λογικό υπερηχοτομογράφημα;
                                                                            χοληδόχου, αλλά δεν προβαίνει σε κατευθυντήριες γραμ-
                  Υπάρχουν περιορισμένες αναφορές για τη συχνότητα          μές για το χειρισμό αυτών των ασθενών. Η Εταιρεία Χει-
                  εμφάνισης ΔΣΟ σε ασθενείς με άθικτη χοληδόχο. Παρό-       ρουργικής Πεπτικού Συστήματος, στις κατευθυντήρι-
                  λα αυτά ΔΣΟ έχει πιστοποιηθεί στο 10% ασθενών με συ-      ες γραμμές που ανακοίνωσε το 2006 για τη θεραπευτι-
                  μπτωματική χολολιθίαση και στο 50% σε ασθενείς με άλ-     κή αντιμετώπιση ασθενών με χολολιθίαση ή χολοκυστοπά-
                  γος δεξιού υποχονδρίου και φυσιολογικό υπερηχοτομο-       θεια, συστήνει χολοκυστεκτομή σε ασθενείς με υποτροπι-
                  γράφημα. Παραμένει άγνωστο εάν υπάρχει συσχέτιση          άζοντα επεισόδια άλγους προέλευσης χοληφόρων, επιβε-
                  μεταξύ υπερτονίας του Oddi και δυσλειτουργίας της χο-     βαιωμένη με χολοκυστογραφία, οριοθετώντας παθολογι-
                  ληδόχου. Σε μια αναδρομική μελέτη, στην οποία συμμε-      κό κλάσμα εξώθησης χοληδόχου <30%. n
                  τείχαν 81 ασθενείς με άλγος δεξιού υπο-
                  χονδρίου και φυσιολογική χοληδόχο στο
                  υπερηχοτομογράφημα υποβλήθηκαν σε                     Άλγος δεξιού υποχονδρίου και φυσιολογικό U/S
                  μανομετρία του Oddi και σε δοκιμασία
                  HIDA. Στους 41 ασθενείς με φυσιολογική                        Ηπατικά ένζυμα και αμυλάση
                  HIDA το 57% είχαν ΔΣΟ, ενώ στους 40 με
                  παθολογική HIDA 50% είχαν ΔΣΟ. Συμπε-
                  ρασματικά, σε αυτή την ομάδα των ασθε-          Παθολογικά            Φυσιολογικά         Συντηρητική
                  νών, η ΔΣΟ και η δυσλειτουργία της χο-                                                      θεραπεία
                  ληδόχου μπορεί να εμφανιστούν ταυτό-
                  χρονα ή ανεξάρτητα η μια από την άλλη.     Περαιτέρω διερεύνηση      Δοκιμασία HIDA

                  Ασθενείς με άλγος δεξιού υποχονδρίου,
                  και, φυσιολογικό υπερηχοτομογράφημα,
                                                                    Φυσιολογική              Παθολογική
                  ηπατικά ένζυμα, αμυλάση και λιπάση δυ-
                  νητικά μπορεί να εμφανίσουν ΔΣΟ. Αξιο-
                  λογώντας έναν ασθενή χωρίς αντικειμενι-             ERCP                Χολοκυστεκτομή
                  κά στοιχεία χολοπαγκρεατικής νόσου και                &
                  με ακέραια τη χοληδόχο κύστη, το ερώτη-           Μανομετρία
                  μα που γεννάται είναι κατά πόσον η δια-
                  γνωστική/ θεραπευτική προσέγγιση θα εί-        Επιμονή/υποτροπή       Ύφεση συμπτωμάτων
                  ναι συντηρητική ή θα πρέπει να προχωρή-          συμπτωμάτων
                  σουμε σε περαιτέρω διαγνωστικά και θε-
                  ραπευτικά μέσα επεμβατικού χαρακτήρα.      Αλγόριθμος διαγνωστικής προσπέλασης άλγους δεξιού υποχονδρίου
                  Η διάγνωση δυσλειτουργίας της χοληδό-      (Πηγή: Clin Gastroenterol Hepatol 2008 AGA Institute)




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                                          ÊáôåõèõíôÞñéåò                                                      Ïäçãßåò
 ÊáôåõèõíôÞñéåò Ïäçãßåò




                                                            Áðü ôç Ñþìç óôï Los Angeles
                          ÊñéôÞñéá Ñþìçò ÉÉÉ ãéá ôéò ËåéôïõñãéêÝò Äéáôáñá÷Ýò ôïõ Ãáóôñåíôåñéêïý ÓõóôÞìáôïò
                                                                                                             ãñÜöåé ï Êùíóôáíôßíïò ÆùãñÜöïò
                          Ï äñüìïò ãéá ôç Ñþìç óõíÝ÷éóå ôçí         ôç ãáóôñïäùäåêáäáêôõëéêÞ ðåñéï-           õðïïìÜäåò ôïõ ÉÂS âáóéæüìåíç óôç
                          ðïñåßá ôïõ ôáîéäåýïíôáò ÄõôéêÜ óôï        ÷Þ, ðÜíôá óå áðïõóßá ïðïéáóäÞðïôå         óõ÷íüôçôá ôùí êåíþóåùí, ôï ó÷Þìá
                          Los Angeles ôçò Êáëéöüñíéá, ôïí           ïñãáíéêÞò, óõóôçìáôéêÞò Þ ìåôáâïëé-       ôùí êïðñÜíùí êáé ôá óõìðôþìáôá
                          ÌÜéï ôïõ 2006 ãéá íá áðïêáëýøåé ôá        êÞò íüóïõ. Ôá õðüëïéðá óõìðôþìáôá         êáôÜ ôçí áöüäåõóç. ¼ìùò, ëüãù ôçò
                          íÝá, áíáèåùñçìÝíá êñéôÞñéá óôï åôÞ-       ôá ïðïßá áíáöÝñïíôáí óôá êñéôÞñéá         ðïëõðëïêüôçôáò óôçí êëéíéêÞ ðñÜîç
                          óéï DDW. Óôï ßäñõìá Ñþìçò óõììå-          Ñþìçò ÉÉ äåí êáëýðôïíôáé ðëÝïí áðü        áëëÜ êáé ëüãù åëëåßøåùò êáëÜ ôåê-
                          ôÝ÷ïõí ðÜíù áðü 100 äéåèíåßò åéäéêïß      ôçí ´´ïìðñÝëá´´ ôçò ëåéôïõñãéêÞò äõ-      ìçñéùìÝíùí âéâëéïãñáöéêþí äåäïìÝ-
                          óå èÝìáôá ëåéôïõñãéêþí äéáôáñá÷þí         óðåøßáò. Åðßóçò äçìéïõñãïýíôáé äýï        íùí, ç äçìéïõñãßá-áíáèåþñçóç ôùí
                          ôïõ ãáóôñåíôåñéêïý óõóôÞìáôïò             õðïïìÜäåò, ïìÜäá ó÷åôéæüìåíç ìå           õðïïìÜäùí ôïõ IBS âáóßóôçêå ìüíï
                          (Functional Gastrointestinal Disorders,   ãåýìá êáé ïìÜäá ó÷åôéæüìåíç ìå Üë-        óôç óýóôáóç ôùí êïðñÜíùí, êÜôé ôï
                          FGID).                                    ãïò, äßíïíôáò ôéò ïíïìáóßåò óýíäñï-       ïðïßï õðïóôçñßæïõí êáé ðñüóöáôåò
                                                                    ìá åðéãáóôñéêïý Üëãïõò êáé ìåôáãåõ-       ìåëÝôåò.
                          Ïé ìåßæïíåò áëëáãÝò ïé ïðïßåò Ýëáâáí
                                                                    ìáôéêü distress óýíäñïìï. Ðñïò ôï
                          ÷þñá óôá áíáèåùñçìÝíá êñéôÞñéá                                                      Ç íÝá ðñïôåéíüìåíç ôáîéíüìçóç ç
                                                                    ðáñüí ôá íÝá áõôÜ óýíäñïìá ðñÝðåé
                          Ñþìçò ÉÉÉ, ðåñéëáìâÜíïõí:                                                           ïðïßá âáóßóôçêå ìüíï óôç óýóôáóç
                                                                    íá ÷ñçóéìïðïéïýíôáé ìüíï ãéá åñåõ-
                          1. Åðáíáðñïóäéïñéóìü ôïõ áðáéôïý-                                                   ôùí êïðñÜíùí åßíáé: IBS ìå äõóêïéëé-
                                                                    íçôéêïýò óêïðïýò êáé ü÷é óôçí êëéíéêÞ
                             ìåíïõ ÷ñïíéêïý ðëáéóßïõ ãéá ôçí                                                  üôçôá, IBS ìå äéÜññïéá, ìéêôü IBS êáé
                                                                    ðñÜîç, ìÝ÷ñé ôçí ðëÞñç áîéïëüãçóÞ
                             ðëÞñç ôáýôéóç ôïõ óõìðôþìáôïò                                                    ÉÂS áêáèüñéóôï.
                                                                    ôïõò.
                             ìå ôá äéáãíùóôéêÜ êñéôÞñéá.
                                                                    Ðëçñüôçôá êáé ðñþéìïò êïñåóìüò            Ïé áóèåíåßò ìå ìéêôü IBS åìöáíßæïõí
                          2. ÁëëáãÝò óôá êñéôÞñéá ôáîéíüìçóçò
                                                                    áíôéðñïóùðåýïõí ìéá îå÷ùñéóôÞ             óêëçñÜ êáé ðïëôþäç êüðñáíá áíÜ
                             (ï ìçñõêáóìüò ðëÝïí áíÞêåé óôéò
                                                                    ïìÜäá, äéáöïñåôéêÞ áðü ôç íáõôßá          ðåñéüäïõò ùñþí Þ çìåñþí, åíþ ïé
                             ãáóôñïäùäåêáäáêôõëéêÝò ëåéôïõñ-
                                                                    êáé ôïí Ýìåôï. ÕðÜñ÷ïõí ðëÝïí äýï         áóèåíåßò ìå åíáëëáãÝò ôùí ´´óõíç-
                             ãéêÝò äéáôáñá÷Ýò, êáé ôï óýíäñïìï
                                                                    äéáöïñåôéêÝò ïíôüôçôåò -óýíäñïìá-         èåéþí´´ ôïõ åíôÝñïõ áëëÜæïõí õðï-
                             êïéëéáêïý ëåéôïõñãéêïý Üëãïõò
                                                                    ôá ïðïßá êáèïñßóôçêáí óôá êñéôÞñéá        ïìÜäá áíÜ ðåñéüäïõò åâäïìÜäùí Þ
                             áðïôåëåß îå÷ùñéóôÞ êáôçãïñßá êáé
                                                                    Ñþìçò ÉÉÉ: ôï óýíäñïìï êõêëéêþí åìÝ-      êáé ìçíþí. Ôï ó÷Þìá ôùí êïðñÜíùí
                             ü÷é ëåéôïõñãéêÞ äéáôáñá÷Þ ôïõ ðá-
                                                                    ôùí êáé ç ÷ñüíéá éäéïðáèÞò íáõôßá.        êáèïñßæåôáé óýìöùíá ìå ôçí êëßìáêá
                             ÷Ýïò åíôÝñïõ).
                                                                                                              Bristol óõó÷åôßæoíôÜò ôï ìå ôï ÷ñüíï
                          3. ÐñïóèÞêç ðáéäéáôñéêþí êáôçãïñé-        Ôþñá, üóïí áöïñÜ ôá êñéôÞñéá ôùí
                                                                                                              äéÝëåõóÞò ôïõò áðü ôï Ýíôåñï.
                             þí.                                    ëåéôïõñãéêþí äéáôáñá÷þí ôïõ ðá÷Ý-
                          4. Áîéïëüãçóç ôçò óýóôáóçò-ìïñöÞò         ïò åíôÝñïõ êáé ôùí õðïïìÜäùí ôïõ          Êëåßíïíôáò, ç óçìáíôéêüôåñç áëëáãÞ
                             ôùí êïðñÜíùí ãéá ôïí êáèïñéóìü         óõíäñüìïõ åõåñÝèéóôïõ åíôÝñïõ, ïé         ç ïðïßá Ýëáâå ÷þñá óôéò ëåéôïõñãéêÝò
                             ôùí õðïïìÜäùí ôïõ óõíäñüìïõ            êõñéüôåñåò áëëáãÝò ðïõ åðéôåëÝóèç-        äéáôáñá÷Ýò ôçò ÷ïëçäü÷ïõ êýóôåùò
                             åõåñÝèéóôïõ åíôÝñïõ (äéÜññïéá Þ        êáí åßíáé:                                êáé ôïõ óöéãêôÞñá ôïõ Oddi, åßíáé üôé
                             äõóêïéëéüôçôá).                        1. ÅéóáãùãÞ ôçò óõ÷íüôçôáò ôùí óõ-        ðëÝïí, äåí áíáöÝñåôáé ãåíéêÜ óáí
                          5. Áõóôçñüôåñá êñéôÞñéá ãéá ôç äõ-           ìðôùìÜôùí óáí ´´êáôþöëé´´ ãéá íá       ëåéôïõñãéêÝò äéáôáñá÷Ýò ôùí ÷ïëç-
                             óëåéôïõñãßá ôçò ÷ïëçäü÷ïõ êýóôå-          óõíáíôÞóïõí ôá êñéôÞñéá (ð.÷. ôñåéò    öüñùí, áëëÜ åöåîÞò ëáìâÜíåôáé õð´
                             ùò êáé ôïõ óöéêôÞñá ôïõ Oddi.             ïé ðåñéóóüôåñåò çìÝñåò ôï ìÞíá ãéá     üøéí ôï áíôßóôïé÷ï áíáôïìéêü óçìåßï
                          Óôá êñéôÞñéá Ñþìçò ÉÉÉ áíáèåùñÞèçêå          ôïõò ôñåéò ôåëåõôáßïõò ìÞíåò)          ãÝíåóçò ôïõ ðñïâëÞìáôïò.
                          åðßóçò êáé ï ïñéóìüò ôçò ëåéôïõñãéêÞò     2. ÄéÜñêåéá óõìðôùìÜôùí (ìåéþèçêáí        Åðßóçò ï üñïò billiary- like syndrome
                          äõóðåøßáò äßíïíôáò íÝåò äéáóôÜóåéò.          ðåñéóóüôåñï áðü Ýîé ìÞíåò)             áíáðôý÷èçêå óõíáéíåôéêÜ:
                          ¸ôóé ðëÝïí óáí ëåéôïõñãéêÞ äõóðå-         3. ÐëÞñçò äéÜêñéóç ôùí õðïïìÜäùí          1. ¢ëãïò åíôïðéóìÝíï óôï åðéãÜóôñéï
                          øßá ïñßæåôáé, Ýíá Þ ðåñéóóüôåñá óõ-          ôïõ åõåñÝèéóôïõ åíôÝñïõ.                  Þ/ êáé óôï äåîéü Üíù ôåôáñôçìüñéï
                          ìðôþìáôá ôá ïðïßá åìöáíßæïíôáé áðü        Ç åðéôñïðÞ Ñþìçò ÉÉ äçìéïýñãçóå           2. ÕðïôñïðéÜæïíôá åðåéóüäéá åìöá-




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                       íéæüìåíá óå äéáöïñåôéêÜ ÷ñïíéêÜ           ôçôá ôïõ áóèåíïýò Þ ôïí ïäçãïýí            1. Óõíäõáóìüò ìå íáõôßá Þ Ýìåôï
                       äéáóôÞìáôá (ü÷é êáèçìåñéíÜ)               óôï íïóïêïìåßï.                            2. Áêôéíïâïëåß óôçí ðåñéï÷Þ ôçò ðëÜ-
                    3. Åðåéóüäéá Üëãïõò äéÜñêåéáò 30 ëå-                                                       ôçò Þ óôç äåîéÜ ùìïðëáôéáßá ÷þñá
                       ðôþí Þ êáé ðåñéóóüôåñï, ìå áõîá-        Åíéó÷õôéêÜ óõìðôþìáôá åßíáé åÜí ï               êáé
                                                               ðüíïò åìöáíéóôåß ìå Ýíá áðü ôá ðá-




                                                                                                                                                                 ÊáôåõèõíôÞñéåò Ïäçãßåò
                       íüìåíç Ýíôáóç (ìÝóç Þ õøçëÞ) ôá                                                      3. ÍõêôåñéíÞ áöýðíéóç.
                       ïðïßá åðçñåÜæïõí ôçí êáèçìåñéíü-        ñáêÜôù:

                                               ÐÉÍÁÊÁÓ 1: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÇ ËÅÉÔÏÕÑÃÉÊÇ ÄÕÓÐÅØÉÁ
                                           ÄéÜñêåéá óõìðôùìÜôùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò,
                                                  êáé ôá ïðïßá åìöáíßæïíôáé ìå Ýíá Þ ðåñéóóüôåñá áðü ôá ðáñáêÜôù:
                     * ÌåôáãåõìáôéêÞ ðëçñüôçôá                                        * Åðéãáóôñéêü Üëãïò
                     * Ðñþéìïò êïñåóìüò                                               * Åðéãáóôñéêüò êáýóïò
                                                                                 ÊÁÉ
                                 * ÊáíÝíá óôïé÷åßï éóôéêÞò âëÜâçò (óõìðåñéëáìâáíïìÝíçò ôçò åíäïóêüðçóçò ôïõ áíùôÝñïõ ðåðôéêïý)
                                                               ôï ïðïßï íá äéêáéïëïãåß ôá óõìðôþìáôá.

                                          ÐÉÍÁÊÁÓ 2: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÅÐÉÃÁÓÔÑÉÊÏÕ ÁËÃÏÕÓ
                                      ÄéÜñêåéá ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, ìå ÏËÁ ôá ðáñáêÜôù:
                     Ðüíïò êáé êáýóïò ôá ïðïßá:       * ÅíáëëÜóóïíôáé
                                                      * Åíôïðßæïíôáé óôï åðéãÜóôñéï, ôïõëÜ÷éóôïí ìÝóçò åíôÜóåùò, ìéá öïñÜ ôçí åâäïìÜäá
                     Êáé Ï×É                          1. ãåíéêåõìÝíá Þ åíôïðéóìÝíá óå Üëëç ðåñéï÷Þ ôçò êïéëßáò Þ ôïõ èþñáêá
                                                      2. íá åðÝñ÷åôáé áíáêïýöéóç ìå ôçí áöüäåõóç Þ ôçí åêôüíùóç áåñßùí
                                                      3. íá ðëçñïß ôá êñéôÞñéá ãéá äéáôáñá÷Ýò ôçò ÷ïëçäü÷ïõ êýóôçò Þ ôïõ óöéãêôÞñá ôïõ Oddi

                                      ÐÉÍÁÊÁÓ 3: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÌÅÔÁÃÅÕÌÁÔÉÊÏ DISTRESS ÓÕÍÄÑÏÌÏ
                                          ÔïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò 6 ôåëåõôáßïõò ìÞíåò, ìå Ýíá áðü ôá ðáñáêÜôù:
                     * ÌåôáãåõìáôéêÝò åíï÷ëÞóåéò      1. ïé ïðïßåò åìöáíßæïíôáé ìåôÜ áðü êáíïíéêïý ìåãÝèïõò ãåýìáôá
                                                      2. ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò ôçí åâäïìÜäá
                                                                                  ¹
                     * Ðñþéìïò êïñåóìüò               1. ðïõ åìðïäßæåé ôçí ïëïêëÞñùóç åíüò êáíïíéêïý ìåãÝèïõò ãåýìáôïò
                                                      2. êáé åìöáíßæåôáé ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò ôçí åâäïìÜäá

                                           ÐÉÍÁÊÁÓ 4: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÊÕÊËÉÊÙÍ ÅÌÅÔÙÍ
                                                    ÔïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, ìå:
                    * ÔõðéêÜ åðåéóüäéá åìÝôùí ìå ïîåßá Ýíáñîç êáé äéÜñêåéá 1 åâäïìÜäáò ôïõëÜ÷éóôïí
                    * 3 Þ ðåñéóóüôåñá îå÷ùñéóôÜ åðåéóüäéá ôá ðñïçãïýìåíá Ýôç
                    * Áðïõóßá íáõôßáò êáé åìÝôùí ìåôáîý ôùí åðåéóïäßùí
                                 Åíéó÷õôéêÜ êñéôÞñéá: Éóôïñéêü êåöáëáëãßáò, ôýðïõ çìéêñáíßáò Þ ïéêïãåíåéáêïý éóôïñéêïý çìéêñáíßáò.

                                              ÐÉÍÁÊÁÓ 5: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÇ ×ÑÏÍÉÁ ÉÄÉÏÐÁÈÇ ÍÁÕÔÉÁ
                                                   ÄéÜñêåéá åðåéóïäßùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç 6 ìÞíåò ðñéí.
                    * Íáõôßá ç ïðïßá åìöáíßæåôáé ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò êáôÜ ôç äéÜñêåéá ôçò åâäïìÜäáò ôïõò 3 ôåëåõôáßïõò ìÞíåò
                    * Äåí áêïëïõèåß óõíÞèùò Ýìåôïò
                    * Áðïõóßá ðáèïëïãéêþí åõñçìÜôùí óôçí åíäïóêüðçóç ôïõ áíùôÝñïõ ðåðôéêïý Þ ìåôáâïëéêÞò íüóïõ ç ïðïßá äéêáéïëïãåß
                      ôç íáõôßá

                                        ÐÉÍÁÊÁÓ 6: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÅÕÅÑÅÈÉÓÔÏÕ ÅÍÔÅÑÏÕ
                         ÄéÜñêåéá åðåéóïäßùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç 6 ìÞíåò ðñéí, áðïôåëïýìåíá áðü õðïôñïðéÜæïíôá êïéëéáêÜ Üëãç
                                               Þ äõóöïñßá**, óå óõíäõáóìü ìå äýï Þ ðåñéóóüôåñá áðü ôá áêüëïõèá:
                    * ¾öåóç óõìðôùìÜôùí ìå ôéò êåíþóåéò êáé /Þ
                    * Ýíáñîç ôùí óõìðôùìÜôùí ðïõ óõíäõÜæåôáé ìå áëëáãÞ ôçò óõ÷íüôçôáò ôùí êåíþóåùí êáé /Þ
                    * Ýíáñîç ôùí óõìðôùìÜôùí ðïõ óõíäõÜæåôáé ìå áëëáãÞ ôçò ìïñöÞò ôùí êïðñÜíùí.
                                                   ** Ùò äõóöïñßá ðåñéãñÜöåôáé ç äõóÜñåóôç áßóèçóç êáé ü÷é ðüíïò




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Appendix A



Rome III
Diagnostic
Criteria for
Functional
Gastrointestinal
Disorders




                   
 Appendix A: Rome III Diagnostic Criteria for FGIDs

A. Functional Esophageal Disorders
A1. Functional Heartburn
 Diagnostic criteria* Must include all of the following:
 . Burning retrosternal discomfort or pain
 . Absence of evidence that gastroesophageal acid reflux is the cause of the
     symptom
 . Absence of histopathology-based esophageal motility disorders
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

A2. Functional Chest Pain of Presumed Esophageal Origin
 Diagnostic criteria* Must include all of the following:
 . Midline chest pain or discomfort that is not of burning quality
 . Absence of evidence that gastroesophageal reflux is the cause of the symptom
 . Absence of histopathology-based esophageal motility disorders
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

A3. Functional Dysphagia
 Diagnostic criteria* Must include all of the following:
 . Sense of solid and/or liquid foods sticking, lodging, or passing abnormally
     through the esophagus
 . Absence of evidence that gastroesophageal reflux is the cause of the symptom
 . Absence of histopathology-based esophageal motility disorders
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

A4. Globus
 Diagnostic criteria* Must include all of the following:
 . Persistent or intermittent, nonpainful sensation of a lump or foreign body
    in the throat
 . Occurrence of the sensation between meals
 . Absence of dysphagia or odynophagia
 . Absence of evidence that gastroesophageal reflux is the cause of the symptom
 . Absence of histopathology-based esophageal motility disorders
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis
Appendix A: Rome III Diagnostic Criteria for FGIDs        

B. Functional Gastroduodenal Disorders
B1. FUNCTIONAL DYSPEPSIA
  Diagnostic criteria* Must include:
  . One or more of the following:
     a. Bothersome postprandial fullness
     b. Early satiation
     c. Epigastric pain
     d. Epigastric burning
  AND
  . No evidence of structural disease (including at upper endoscopy) that is likely
     to explain the symptoms
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

B1a. Postprandial Distress Syndrome
  Diagnostic criteria* Must include one or both of the following:
  . Bothersome postprandial fullness, occurring after ordinary-sized meals,
     at least several times per week
  . Early satiation that prevents finishing a regular meal, at least several times
     per week
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

  Supportive criteria
  . Upper abdominal bloating or postprandial nausea or excessive belching
     can be present
  . Epigastric pain syndrome may coexist

B1b. Epigastric Pain Syndrome
  Diagnostic criteria* Must include all of the following:
  . Pain or burning localized to the epigastrium of at least moderate severity,
     at least once per week
  . The pain is intermittent
  . Not generalized or localized to other abdominal or chest regions
  . Not relieved by defecation or passage of flatus
  . Not fulfilling criteria for gallbladder and sphincter of Oddi disorders
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

  Supportive criteria
  . The pain may be of a burning quality, but without a retrosternal component
  . The pain is commonly induced or relieved by ingestion of a meal, but may
     occur while fasting
  . Postprandial distress syndrome may coexist
 Appendix A: Rome III Diagnostic Criteria for FGIDs

B2. BELCHING DISORDERS

B2a. Aerophagia
 Diagnostic criteria* Must include all of the following:
  . Troublesome repetitive belching at least several times a week
 . Air swallowing that is objectively observed or measured
  * Criteria fulfilled for the last  months with symptom
    onset at least  months prior to diagnosis

B2b. Unspecified Excessive Belching
 Diagnostic criteria* Must include all of the following:
  . Troublesome repetitive belching at least several times a week
 . No evidence that excessive air swallowing underlies the symptom
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis


B3. NAUSEA AND VOMITING DISORDERS

B3a. Chronic Idiopathic Nausea
 Diagnostic criteria* Must include all of the following:
  . Bothersome nausea occurring at least several times per week
 . Not usually associated with vomiting
 . Absence of abnormalities at upper endoscopy or metabolic disease
     that explains the nausea
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

B3b. Functional Vomiting
 Diagnostic criteria* Must include all of the following:
  . On average one or more episodes of vomiting per week
 . Absence of criteria for an eating disorder, rumination, or major
     psychiatric disease according to DSM-IV
 . Absence of self-induced vomiting and chronic cannabinoid use and
     absence of abnormalities in the central nervous system or metabolic
     diseases to explain the recurrent vomiting
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis
Appendix A: Rome III Diagnostic Criteria for FGIDs               

B3c. Cyclic Vomiting Syndrome
 Diagnostic criteria Must include all of the following:
  . Stereotypical episodes of vomiting regarding onset (acute) and duration
     (less than one week)
 . Three or more discrete episodes in the prior year
 . Absence of nausea and vomiting between episodes

  Supportive criterion
  History or family history of migraine headaches

B4. Rumination Syndrome in Adults
 Diagnostic criteria Must include both of the following:
 . Persistent or recurrent regurgitation of recently ingested food into the mouth
     with subsequent spitting or remastication and swallowing
 . Regurgitation is not preceded by retching

  Supportive criteria
  . Regurgitation events are usually not preceded by nausea
  . Cessation of the process when the regurgitated material becomes acidic
  . Regurgitant contains recognizable food with a pleasant taste

C. Functional Bowel Disorders
C1. Irritable Bowel Syndrome
 Diagnostic criterion*
 Recurrent abdominal pain or discomfort** at least  days/month in the last
  months associated with two or more of the following:
 . Improvement with defecation
 . Onset associated with a change in frequency of stool
 . Onset associated with a change in form (appearance) of stool
  * Criterion fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis
  ** “Discomfort” means an uncomfortable sensation not described as pain.
  In pathophysiology research and clinical trials, a pain/discomfort frequency of at least
   days a week during screening evaluation is recommended for subject eligibility.

C2. Functional Bloating
 Diagnostic criteria* Must include both of the following:
 . Recurrent feeling of bloating or visible distension at least  days/month in
     the last  months
 . Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel
     syndrome, or other functional GI disorder
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis
   Appendix A: Rome III Diagnostic Criteria for FGIDs

C3. Functional Constipation
 Diagnostic criteria*
 . Must include two or more of the following:
     a. Straining during at least % of defecations
     b. Lumpy or hard stools in at least % of defecations
     c. Sensation of incomplete evacuation for at least % of defecations
     d. Sensation of anorectal obstruction/blockage for at least % of defecations
     e. Manual maneuvers to facilitate at least % of defecations (e.g., digital
        evacuation, support of the pelvic floor)
     f. Fewer than three defecations per week
 . Loose stools are rarely present without the use of laxatives
 . Insufficient criteria for irritable bowel syndrome
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

C4. Functional Diarrhea
 Diagnostic criterion*
 Loose (mushy) or watery stools without pain occurring in at least % of stools
  * Criterion fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

C5. Unspecified Functional Bowel Disorder
 Diagnostic criterion*
 Bowel symptoms not attributable to an organic etiology that do not meet criteria
 for the previously defined categories
  * Criterion fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis


D. Functional Abdominal Pain Syndrome
D. Functional Abdominal Pain Syndrome
  Diagnostic criteria* Must include all of the following:
  . Continuous or nearly continuous abdominal pain
  . No or only occasional relationship of pain with physiological events
     (e.g., eating, defecation, or menses)
  . Some loss of daily functioning
  . The pain is not feigned (e.g., malingering)
  . Insufficient symptoms to meet criteria for another functional gastrointestinal
     disorder that would explain the pain
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis
Appendix A: Rome III Diagnostic Criteria for FGIDs        

E. Functional Gallbladder and Sphincter of Oddi Disorders
E. Functional Gallbladder and Sphincter of Oddi Disorders
  Diagnostic criteria Must include episodes of pain located in the epigastrium
                       and/or right upper quadrant and all of the following:
  .   Episodes lasting  minutes or longer
  .   Recurrent symptoms occurring at different intervals (not daily)
  .   The pain builds up to a steady level
  .   The pain is moderate to severe enough to interrupt the patient’s daily activities
       or lead to an emergency department visit
  .   The pain is not relieved by bowel movements
  .   The pain is not relieved by postural change
  .   The pain is not relieved by antacids
  .   Exclusion of other structural disease that would explain the symptoms

  Supportive criteria
  The pain may present with one or more of the following:
  . Associated with nausea and vomiting
  . Radiates to the back and/or right infra subscapular region
  . Awakens from sleep in the middle of the night

E1. Functional Gallbladder Disorder
  Diagnostic criteria Must include all of the following:
  . Criteria for functional gallbladder and sphincter of Oddi disorder
  . Gallbladder is present
  . Normal liver enzymes, conjugated bilirubin, and amylase/lipase

E2. Functional Biliary Sphincter of Oddi Disorder
  Diagnostic criteria Must include both of the following:
  . Criteria for functional gallbladder and sphincter of Oddi disorder
  . Normal amylase/lipase

  Supportive criterion
  Elevated serum transaminases, alkaline phosphatase, or conjugated bilirubin
  temporarily related to at least two pain episodes

E3. Functional Pancreatic Sphincter of Oddi Disorder
  Diagnostic criteria Must include both of the following:
  . Criteria for functional gallbladder and sphincter of Oddi disorder and
  . Elevated amylase/lipase
   Appendix A: Rome III Diagnostic Criteria for FGIDs

F. Functional Anorectal Disorders
F1. Functional Fecal Incontinence
  Diagnostic criteria*
  . Recurrent uncontrolled passage of fecal material in an individual with a
     developmental age of at least  years and one or more of the following:
     a. Abnormal functioning of normally innervated and structurally
        intact muscles
     b. Minor abnormalities of sphincter structure and/or innervation
     c. Normal or disordered bowel habits, (i.e., fecal retention or diarrhea)
     d. Psychological causes
  AND
  . Exclusion of all the following:
     a. Abnormal innervation caused by lesion(s) within the brain (e.g., dementia),
        spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple
        sclerosis), or as part of a generalized peripheral or autonomic neuropathy
        (e.g., due to diabetes)
     b. Anal sphincter abnormalities associated with a multisystem disease
        (e.g., scleroderma)
     c. Structural or neurogenic abnormalities believed to be the major or primary
        cause of fecal incontinence
  * Criteria fulfilled for the last  months


F2. FUNCTIONAL ANORECTAL PAIN

F2a. Chronic Proctalgia
  Diagnostic criteria* Must include all of the following:
  . Chronic or recurrent rectal pain or aching
  . Episodes last  minutes or longer
  . Exclusion of other causes of rectal pain such as ischemia, inflammatory
     bowel disease, cryptitis, intramuscular abscess, anal fissure, hemorrhoids,
     prostatitis, and coccygodynia
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis

  Chronic proctalgia may be further characterized into levator ani syndrome
  or unspecified anorectal pain based on digital rectal examination.

  F2a.1. Levator Ani Syndrome
  Diagnostic criterion
  Symptom criteria for chronic proctalgia and tenderness during posterior traction
  on the puborectalis
Appendix A: Rome III Diagnostic Criteria for FGIDs               

  F2a.2. Unspecified Functional Anorectal Pain
  Diagnostic criterion
  Symptom criteria for chronic proctalgia but no tenderness during posterior
  traction on the puborectalis

F2b. Proctalgia Fugax
  Diagnostic criteria Must include all of the following:
  . Recurrent episodes of pain localized to the anus or lower rectum
  . Episodes last from seconds to minutes
  . There is no anorectal pain between episodes
  For research purposes criteria must be fulfilled for  months;
  however, clinical diagnosis and evaluation may be made prior to  months.

F3. Functional Defecation Disorders
  Diagnostic criteria*
  . The patient must satisfy diagnostic criteria for functional constipation**
  . During repeated attempts to defecate must have at least two of the following:
     a. Evidence of impaired evacuation, based on balloon expulsion test
        or imaging
     b. Inappropriate contraction of the pelvic floor muscles (i.e., anal sphincter or
        puborectalis) or less than % relaxation of basal resting sphincter pressure
        by manometry, imaging, or EMG
     c. Inadequate propulsive forces assessed by manometry or imaging
  * Criteria fulfilled for the last  months with symptom onset
    at least  months prior to diagnosis
  ** Diagnostic criteria for functional constipation:
  () Must include two or more of the following: (a) Straining during at least % of defeca-
  tions, (b) Lumpy or hard stools in at least % of defecations, (c) Sensation of incomplete
  evacuation for at least % of defecations, (d) Sensation of anorectal obstruction/blockage
  for at least % of defecations, (e) Manual maneuvers to facilitate at least % of defeca-
  tions (e.g., digital evacuation, support of the pelvic floor), (f ) Fewer than three defecations
  per week.
  () Loose stools are rarely present without the use of laxatives.
  () Insufficient criteria for irritable bowel syndrome.

F3a. Dyssynergic Defecation
  Diagnostic criterion
  Inappropriate contraction of the pelvic floor or less than % relaxation of basal
  resting sphincter pressure with adequate propulsive forces during attempted
  defecation

F3b. Inadequate Defecatory Propulsion
  Diagnostic criterion
  Inadequate propulsive forces with or without inappropriate contraction or less
  than % relaxation of the anal sphincter during attempted defecation
 Appendix A: Rome III Diagnostic Criteria for FGIDs

G. Childhood Functional GI Disorders: Infant/Toddler
G1. Infant Regurgitation
 Diagnostic criteria Must include both of the following in otherwise healthy infants
                     3 weeks to 12 months of age:
 . Regurgitation two or more times per day for  or more weeks
 . No retching, hematemesis, aspiration, apnea, failure to thrive, feeding or
     swallowing difficulties, or abnormal posturing

G2. Infant Rumination Syndrome
 Diagnostic criteria Must include all of the following for at least 3 months:
 . Repetitive contractions of the abdominal muscles, diaphragm, and tongue
 . Regurgitation of gastric content into the mouth, which is either expectorated
     or rechewed and reswallowed
 . Three or more of the following:
     a. Onset between  and  months
     b. Does not respond to management for gastroesophageal reflux disease,
        or to anticholinergic drugs, hand restraints, formula changes, and
        gavage or gastrostomy feedings
     c. Unaccompanied by signs of nausea or distress
     d. Does not occur during sleep and when the infant is interacting with
        individuals in the environment

G3. Cyclic Vomiting Syndrome
 Diagnostic criteria Must include both of the following:
 . Two or more periods of intense nausea and unremitting vomiting or retching
    lasting hours to days
 . Return to usual state of health lasting weeks to months

G4. Infant Colic
 Diagnostic criteria  Must include all of the following in infants from birth to
                      4 months of age:
  . Paroxysms of irritability, fussing or crying that starts and stops without
     obvious cause
  . Episodes lasting  or more hours/day and occurring at least  days/wk for
     at least  week
  . No failure to thrive

G5. Functional Diarrhea
 Diagnostic criteria Must include all of the following:
 . Daily painless, recurrent passage of three or more large, unformed stools
 . Symptoms that last more than  weeks
 . Onset of symptoms that begins between  and  months of age
 . Passage of stools that occurs during waking hours
 . There is no failure-to-thrive if caloric intake is adequate
Appendix A: Rome III Diagnostic Criteria for FGIDs            

G6. Infant Dyschezia
 Diagnostic criteria Must include both of the following in an infant less than 6 months of age
 . At least  minutes of straining and crying before successful passage of soft stools
 . No other health problems

G7. Functional Constipation
 Diagnostic criteria Must include one month of at least two of the following
                     in infants up to 4 years of age:
 . Two or fewer defecations per week
 . At least one episode/week of incontinence after the acquisition of toileting skills
 . History of excessive stool retention
 . History of painful or hard bowel movements
 . Presence of a large fecal mass in the rectum
 . History of large diameter stools which may obstruct the toilet
 Accompanying symptoms may include irritability, decreased appetite, and/or early
 satiety. The accompanying symptoms disappear immediately following passage of a
 large stool.

H. Childhood Functional GI Disorders: Child/Adolescent

H1. VOMITING AND AEROPHAGIA

H1a. Adolescent Rumination Syndrome
 Diagnostic criteria* Must include all of the following:
 . Repeated painless regurgitation and rechewing or expulsion of food that
    a. begin soon after ingestion of a meal
    b. do not occur during sleep
    c. do not respond to standard treatment for gastroesophageal reflux
 . No retching
 . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
    that explains the subject’s symptoms
  * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis

H1b. Cyclic Vomiting Syndrome
 Diagnostic criteria Must include both of the following:
 . Two or more periods of intense nausea and unremitting vomiting or retching lasting
    hours to days
 . Return to usual state of health lasting weeks to months

H1c. Aerophagia
 Diagnostic criteria* Must include at least two of the following:
 . Air swallowing
 . Abdominal distention due to intraluminal air
 . Repetitive belching and/or increased flatus
  * Criteria fulfilled at least once per week for at least  months prior to diagnosis
 Appendix A: Rome III Diagnostic Criteria for FGIDs

H2. ABDOMINAL PAIN-RELATED FUNCTIONAL GI DISORDERS

H2a. Functional Dyspepsia
 Diagnostic criteria* Must include all of the following:
 . Persistent or recurrent pain or discomfort centered in the upper abdomen
    (above the umbilicus)
 . Not relieved by defecation or associated with the onset of a change in stool
    frequency or stool form (i.e., not irritable bowel syndrome)
 . No evidence of an inflammatory, anatomic, metabolic or neoplastic process
    that explains the subject’s symptoms
  * Criteria fulfilled at least once per week for at least  months prior to diagnosis

H2b. Irritable Bowel Syndrome
 Diagnostic criteria* Must include both of the following:
 . Abdominal discomfort** or pain associated with two or more of the following
    at least % of the time:
    a. Improvement with defecation
    b. Onset associated with a change in frequency of stool
    c. Onset associated with a change in form (appearance) of stool
 . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
    that explains the subject’s symptoms
  * Criteria fulfilled at least once per week for at least  months prior to diagnosis
  ** “Discomfort” means an uncomfortable sensation not described as pain.

H2c. Abdominal Migraine
 Diagnostic criteria* Must include all of the following:
 . Paroxysmal episodes of intense, acute periumbilical pain that lasts for
     hour or more
 . Intervening periods of usual health lasting weeks to months
 . The pain interferes with normal activities
 . The pain is associated with  of the following:
    a. Anorexia
    b. Nausea
    c. Vomiting
    d. Headache
    e. Photophobia
    f. Pallor
 . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
    considered that explains the subject’s symptoms
  * Criteria fulfilled two or more times in the preceding  months
Appendix A: Rome III Diagnostic Criteria for FGIDs         

H2d. Childhood Functional Abdominal Pain
 Diagnostic criteria* Must include all of the following:
 . Episodic or continuous abdominal pain
 . Insufficient criteria for other FGIDs
 . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
    that explains the subject’s symptoms
  * Criteria fulfilled at least once per week for at least  months prior to diagnosis

H2d1. Childhood Functional Abdominal Pain Syndrome
 Diagnostic criteria* Must satisfy criteria for childhood functional abdominal pain and
                      have at least 25% of the time one or more of the following:
 . Some loss of daily functioning
 . Additional somatic symptoms such as headache, limb pain, or difficulty
    sleeping
  * Criteria fulfilled at least once per week for at least  months prior to diagnosis


H3. CONSTIPATION AND INCONTINENCE

H3a. Functional Constipation
 Diagnostic criteria* Must include two or more of the following in a child with a
                      developmental age of at least 4 years with insufficient criteria
                      for diagnosis of IBS:
 . Two or fewer defecations in the toilet per week
 . At least one episode of fecal incontinence per week
 . History of retentive posturing or excessive volitional stool retention
 . History of painful or hard bowel movements
 . Presence of a large fecal mass in the rectum
 . History of large diameter stools which may obstruct the toilet
  * Criteria fulfilled at least once per week for at least  months prior to diagnosis

H3b. Nonretentive Fecal Incontinence
 Diagnostic criteria* Must include all of the following in a child with a developmental
                      age at least 4 years:
 . Defecation into places inappropriate to the social context at least once per
    month
 . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
    that explains the subject’s symptoms
 . No evidence of fecal retention
  * Criteria fulfilled for at least  months prior to diagnosis
Appendix B



Comparison Table of
Rome II & Rome III
Adult Diagnostic
Criteria




               
ROME III DIAGNOSTIC CRITERIA                       ROME II DIAGNOSTIC CRITERIA

A. Functional Esophageal Disorders                A. Functional Esophageal Disorders

A1. Functional Heartburn                          A4. Functional Heartburn
Diagnostic criteria*                              At least 12 weeks, which need not be consecutive,
Must include all of the following:                in the preceding 12 months of:

. Burning retrosternal discomfort or pain        . Burning retrosternal discomfort or pain;
. Absence of evidence that gastroesophageal         and
   acid reflux is the cause of the symptom         . Absence of pathologic gastroesophageal
. Absence of histopathology-based                   reflux, achalasia, or other motility disorder
   esophageal motility disorders                     with a recognized pathologic basis.
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis


A2. Functional Chest Pain of                      A3. Functional Chest Pain of
Presumed Esophageal Origin                        Presumed Esophageal Origin
Diagnostic criteria*                              At least 12 weeks, which need not be consecutive,
Must include all of the following:                within the preceding 12 months of:

. Midline chest pain or discomfort that is not   . Midline chest pain or discomfort that is not
   of burning quality                                of burning quality; and
. Absence of evidence that gastroesophageal      . Absence of pathologic gastroesophageal
   reflux is the cause of the symptom                 reflux, achalasia, or other motility disorder
. Absence of histopathology-based                   with a recognized pathologic basis.
   esophageal motility disorders
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis




     
ROME III DIAGNOSTIC CRITERIA                       ROME II DIAGNOSTIC CRITERIA

A3. Functional Dysphagia                          A5. Functional Dysphagia
Diagnostic criteria*                              At least 12 weeks, which need not be consecutive,
Must include all of the following:                in the preceding 12 months of:

. Sense of solid and/or liquid foods sticking,   . Sense of solid and/or liquid foods sticking,
   lodging, or passing abnormally through the        lodging, or passing abnormally through the
   esophagus                                         esophagus; and
. Absence of evidence that gastroesophageal      . Absence of pathologic gastroesophageal
   reflux is the cause of the symptom                 reflux, achalasia, or other motility disorder
. Absence of histopathology-based                   with a recognized pathologic basis.
   esophageal motility disorders
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis


A4. Globus                                        A1. Globus
Diagnostic criteria*                              At least 12 weeks, which need not be consecutive,
Must include all of the following:                in the preceding 12 months of:

. Persistent or intermittent, nonpainful         . The persistent or intermittent sensation of a
   sensation of a lump or foreign body in            lump or foreign body in the throat;
   the throat                                     . Occurrence of the sensation between meals;
. Occurrence of the sensation between meals      . Absence of dysphagia and odynophagia; and
. Absence of dysphagia or odynophagia            . Absence of pathologic gastroesophageal
. Absence of evidence that gastroesophageal         reflux, achalasia, or other motility disorder
   reflux is the cause of the symptom                 with a recognized pathologic basis (e.g.,
. Absence of histopathology-based                   scleroderma of the esophagus).
   esophageal motility disorders
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis

Rome III criteria do not include unspecified      A6. Unspecified Functional
functional esophageal disorder as in Rome II.     Esophageal Disorder
                                                  At least 12 weeks, which need not be consecutive,
                                                  in the preceding 12 months of:

                                                  . Unexplained symptoms attributed to the
                                                     esophagus that do not fit into the previously
                                                     described categories; and
                                                  . Absence of pathologic gastroesophageal
                                                     reflux, achalasia, or other motility disorder
                                                     with a recognized pathologic basis.

                                                                                          
ROME III DIAGNOSTIC CRITERIA                         ROME II DIAGNOSTIC CRITERIA

B. Functional Gastroduodenal                        B. Functional Gastroduodenal
Disorders                                           Disorders

Note major changes in classification for dyspepsia
and nausea and vomiting disorders

B1. Functional Dyspepsia                            B1. Functional Dyspepsia
Diagnostic criteria*                                At least 12 weeks, which need not be consecutive,
Must include:                                       in the preceding 12 months of:

. One or more of the following:                    . Persistent or recurrent symptoms (pain
   a. Bothersome postprandial fullness                 or discomfort centered in the upper
   b. Early satiation                                  abdomen);
   c. Epigastric pain                               . No evidence of organic disease (including
   d. Epigastric burning                               at upper endoscopy) that is likely to explain
AND                                                    the symptoms; and
. No evidence of structural disease (including     . No evidence that dyspepsia is exclusively
   at upper endoscopy) that is likely to explain       relieved by defecation or associated with the
   the symptoms                                        onset of a change in stool frequency or stool
* Criteria fulfilled for the last  months with         form.
  symptom onset at least  months prior to
  diagnosis                                           B1a. Ulcer-like dyspepsia
                                                      Pain centered in the upper abdomen is the
  B1a. Postprandial Distress Syndrome                 predominant (most bothersome) symptom.
  Diagnostic criteria*
  Must include one or both of the following:          B1b. Dysmotility-like dyspepsia
                                                      An unpleasant or troublesome nonpainful
  . Bothersome postprandial fullness,
                                                      sensation (discomfort) centered in the
     occurring after ordinary-sized meals, at
                                                      upper abdomen is the predominant
     least several times per week
                                                      symptom; this sensation may be
  . Early satiation that prevents finishing a
                                                      characterized by or associated with upper
     regular meal, at least several times per
                                                      abdominal fullness, early satiety, bloating,
     week
                                                      or nausea.
   * Criteria fulfilled for the last  months with
     symptom onset at least  months prior to         B1c. Unspecified (nonspecific) dyspepsia
     diagnosis                                        Symptomatic patients whose symptoms
  Supportive criteria                                 do not fulfill the criteria for ulcer-like or
  . Upper abdominal bloating or                      dysmotility-like dyspepsia.
     postprandial nausea or excessive belching
     can be present
  . Epigastric pain syndrome may coexist




     
ROME III DIAGNOSTIC CRITERIA                     ROME II DIAGNOSTIC CRITERIA

B1b. Epigastric Pain Syndrome
Diagnostic criteria*
Must include all of the following:

. Pain or burning localized to the
   epigastrium of at least moderate severity,
   at least once per week
. The pain is intermittent
. Not generalized or localized to other
   abdominal or chest regions
. Not relieved by defecation or passage of
   flatus
. Not fulfilling criteria for gallbladder and
   sphincter of Oddi disorders
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis
Supportive criteria
. The pain may be of a burning quality, but
   without a retrosternal component
. The pain is commonly induced or
   relieved by ingestion of a meal, but may
   occur while fasting
. Postprandial distress syndrome may
   coexist




                                                                        
ROME III DIAGNOSTIC CRITERIA                         ROME II DIAGNOSTIC CRITERIA

B2. Belching Disorders

 B2a. Aerophagia                                   B2. Aerophagia
 Diagnostic criteria*                              At least 12 weeks, which need not be consecutive,
 Must include all of the following:                or more in the preceding 12 months of:

 . Troublesome repetitive belching at least       . Air swallowing that is objectively observed;
    several times a week                              and
 . Air swallowing that is objectively             . Troublesome repetitive belching.
    observed or measured
  * Criteria fulfilled for the last  months with
    symptom onset at least  months prior to
    diagnosis

 B2b. Unspecified Excessive Belching
 Diagnostic criteria*
 Must include all of the following:

 . Troublesome repetitive belching at least
    several times a week
 . No evidence that excessive air swallowing
    underlies the symptom
  * Criteria fulfilled for the last  months with
    symptom onset at least  months prior to
    diagnosis




    
ROME III DIAGNOSTIC CRITERIA                         ROME II DIAGNOSTIC CRITERIA

B3. Nausea and Vomiting Disorders

 B3a. Chronic Idiopathic Nausea
 Diagnostic criteria*
 Must include all of the following:

 . Bothersome nausea occurring at least
    several times per week
 . Not usually associated with vomiting
 . Absence of abnormalities at upper
    endoscopy or metabolic disease that
    explains the nausea
  * Criteria fulfilled for the last  months with
    symptom onset at least  months prior to
    diagnosis

 B3b. Functional Vomiting                          B3. Functional Vomiting
 Diagnostic criteria*                              At least 12 weeks, which need not be consecutive,
 Must include all of the following:                in the preceding 12 months of:

 . On average one or more episodes of             . Frequent episodes of vomiting, occurring
    vomiting per week                                 on at least three separate days in a week over
 . Absence of criteria for an eating disorder,       three months;
    rumination, or major psychiatric disease       . Absence of criteria for an eating disorder,
    according to DSM-IV                               rumination, or major psychiatric disease
 . Absence of self-induced vomiting and              according to DSM-IV;
    chronic cannabinoid use and absence            . Absence of self-induced and medication-
    of abnormalities in the central nervous           induced vomiting; and
    system or metabolic diseases to explain        . Absence of abnormalities in the gut or
    the recurrent vomiting                            central nervous system, and metabolic
  * Criteria fulfilled for the last  months with      diseases to explain the recurrent vomiting.
    symptom onset at least  months prior to
    diagnosis




                                                                                           
ROME III DIAGNOSTIC CRITERIA                          ROME II DIAGNOSTIC CRITERIA

  B3c. Cyclic Vomiting Syndrome
  Diagnostic criteria
  Must include all of the following:

  . Stereotypical episodes of vomiting
     regarding onset (acute) and duration
     (less than one week)
  . Three or more discrete episodes in the
     prior year
  . Absence of nausea and vomiting between
     episodes
  Supportive criteria
  History or family history of migraine
  headaches

B4. Rumination Syndrome in Adults                    A2. Rumination Syndrome
Diagnostic criteria*                                 At least 12 weeks, which need not be consecutive,
Must include both of the following:                  in the preceding 12 months of:

. Persistent or recurrent regurgitation of          . Persistent or recurrent regurgitation of
   recently ingested food into the mouth with           recently ingested food into the mouth with
   subsequent spitting or remastication and             subsequent remastication and swallowing;
   swallowing                                        . Absence of nausea and vomiting;
. Regurgitation is not preceded by retching         . Cessation of the process when the
Supportive criteria                                     regurgitated material becomes acidic; and
                                                     . Absence of pathologic gastroesophageal
. Regurgitation events are usually not
                                                        reflux, achalasia, or other motility disorder
   preceded by nausea
                                                        with a recognized pathologic basis as the
. Cessation of the process when the
                                                        primary disorder.
   regurgitated material becomes acidic
. Regurgitant contains recognizable food
   with a pleasant taste
The Rome III criteria classify rumination as a
functional gastroduodenal disorder. In the Rome II
classification, rumination was considered a func-
tional esophageal disorder.




     
ROME III DIAGNOSTIC CRITERIA                        ROME II DIAGNOSTIC CRITERIA

C. Functional Bowel Disorders                      C. Functional Bowel Disorders

C1. Irritable Bowel Syndrome                       C1. Irritable Bowel Syndrome
Diagnostic criterion*                              At least 12 weeks, which need not be consecutive,
                                                   in the preceding 12 months of abdominal discom-
Recurrent abdominal pain or discomfort** at
                                                   fort or pain that has two out of three features:
least 3 days/month in last 3 months associated
with two or more of the following:                 . Relieved with defecation; and/or
. Improvement with defecation                     . Onset associated with a change in frequency
. Onset associated with a change in frequency        of stool; and/or
   of stool                                        . Onset associated with a change in form
. Onset associated with a change in form             (appearance) of stool.
   (appearance) of stool                           Symptoms that Cumulatively Support the
                                                   Diagnosis of Irritable Bowel Syndrome
* Criterion fulfilled for the last  months with
  symptom onset at least  months prior to         – Abnormal stool frequency (for research
  diagnosis                                          purposes “abnormal” may be defined as
**“Discomfort” means an uncomfortable                greater than  bowel movements per day
  sensation not described as pain.                   and less than  bowel movements per week);
In pathophysiology research and clinical trials,   – Abnormal stool form (lumpy/hard or loose/
  a pain/discomfort frequency of at least  days     watery stool);
  a week during the screening evaluation is
  recommended for subject eligibility.             – Abnormal stool passage (straining, urgency,
                                                     or feeling of incomplete evacuation);
                                                   – Passage of mucus;
                                                   – Bloating or feeling of abdominal distension.

C2. Functional Bloating                            C2. Functional Abdominal Bloating
Diagnostic criteria*                               At least 12 weeks, which need not be consecutive,
Must include both of the following:                in the preceding 12 months of:

. Recurrent feeling of bloating or visible        . Feeling of abdominal fullness, bloating, or
   distension at least  days/month in the last       visible distension; and
    months                                        . Insufficient criteria for a diagnosis of
. Insufficient criteria for a diagnosis of             functional dyspepsia, irritable bowel
   functional dyspepsia, irritable bowel              syndrome, or other functional disorder.
   syndrome, or other functional GI disorder
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis




                                                                                          
ROME III DIAGNOSTIC CRITERIA                       ROME II DIAGNOSTIC CRITERIA

C3. Functional Constipation                       C3. Functional Constipation
Diagnostic criteria*                              At least 12 weeks, which need not be consecutive,
                                                  in the preceding 12 months of two or more of:
. Must include two or more of the following:
   a. Straining during at least % of            . Straining > / of defecations;
      defecations                                 . Lumpy or hard stools > / of defecations;
   b. Lumpy or hard stools in at least % of     . Sensation of incomplete evacuation > / of
      defecations                                    defecations;
   c. Sensation of incomplete evacuation for      . Sensation of anorectal obstruction/blockage
      at least % of defecations                    > / of defecations;
   d. Sensation of anorectal obstruction/         . Manual maneuvers to facilitate > / of
      blockage for at least % of defecations       defecations (e.g., digital evacuation, support
   e. Manual maneuvers to facilitate at              of the pelvic floor); and/or
      least % of defecations (e.g., digital     . <  defecations per week.
      evacuation, support of the pelvic floor)     Loose stools are not present, and there are
   f. Fewer than three defecations per week        insufficient criteria for IBS.
. Loose stools are rarely present without the
   use of laxatives
. Insufficient criteria for irritable bowel
   syndrome
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis


C4. Functional Diarrhea                           C4. Functional Diarrhea
Diagnostic criterion*                             At least 12 weeks, which need not be consecutive,
                                                  in the preceding 12 months of:
Loose (mushy) or watery stools without pain
occurring in at least % of stools               . Loose (mushy) or watery stools
* Criterion fulfilled for the last  months with   . Present > / of the time; and
  symptom onset at least  months prior to        . No abdominal pain.
  diagnosis


C.5. Unspecified Functional Bowel                  C5. Unspecified Functional Bowel
Disorder                                          Disorder
Diagnostic criterion*

Bowel symptoms not attributable to an             Bowel symptoms in the absence of organic
organic etiology that do not meet criteria for    disease that do not fit into the previously
the previously defined categories                  defined categories of functional bowel
                                                  disorders.
* Criterion fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis

     
ROME III DIAGNOSTIC CRITERIA                       ROME II DIAGNOSTIC CRITERIA

D. Functional Abdominal Pain                      D. Functional Abdominal Pain
Syndrome

D. Functional Abdominal Pain                      D1. Functional Abdominal
Syndrome                                          Pain Syndrome
Diagnostic criteria*                              At least 6 months of:
Must include all of the following:
                                                  . Continuous or nearly continuous
. Continuous or nearly continuous                   abdominal pain; and
   abdominal pain                                 . No or only occasional relationship of pain
. No or only occasional relationship of pain        with physiological events (e.g., eating,
   with physiological events (e.g., eating,          defecation, or menses); and
   defecation, or menses)                         . Some loss of daily functioning; and
. Some loss of daily functioning                 . The pain is not feigned (e.g., malingering),
. The pain is not feigned (e.g., malingering)       and
. Insufficient symptoms to meet criteria for       . Insufficient criteria for other functional
   another functional gastrointestinal disorder      gastrointestinal disorders that would
   that would explain the pain                       explain the abdominal pain.
* Criteria fulfilled for the last  months with
  symptom onset at least  months prior to
  diagnosis

The Rome III Criteria do not include Unspecified   D2. Unspecified Functional
Functional Abdominal Pain                         Abdominal Pain

                                                  This is functional abdominal pain that fails to
                                                  reach criteria for functional abdominal pain
                                                  syndrome.




                                                                                         
ROME III DIAGNOSTIC CRITERIA                           ROME II DIAGNOSTIC CRITERIA

E. Functional Gallbladder and                         E. Functional Disorders of the Biliary
Sphincter of Oddi Disorders                           Tract and the Pancreas

E. Functional Gallbladder and                         E1. Gallbladder Dysfunction
Sphincter of Oddi Disorders                           Episodes of severe steady pain located in the epi-
Diagnostic criteria                                   gastrium and right upper quadrant, and all of the
Must include episodes of pain located in the          following:
epigastrium and/or right upper quadrant
                                                      . Symptom episodes last  minutes or more,
and all of the following:
                                                         with pain-free intervals;
. Episodes lasting  minutes or longer              . Symptoms have occurred on one or more
. Recurrent symptoms occurring at different              occasions in the previous  months;
   intervals (not daily)                              . The pain is steady and interrupts daily
. The pain builds up to a steady level                  activities or requires consultation with a
. The pain is moderate to severe enough to              physician;
   interrupt the patient’s daily activities or lead   . There is no evidence of structural
   to an emergency department visit                      abnormalities to explain the symptoms;
. The pain is not relieved by bowel                  . There is abnormal gallbladder functioning
   movements                                             with regard to emptying.
. The pain is not relieved by postural change
. The pain is not relieved by antacids               E2. Sphincter of Oddi Dysfunction
. Exclusion of other structural disease that         Episodes of severe steady pain located in the epi-
   would explain the symptoms                         gastrium and right upper quadrant, and all of the
Supportive criteria                                   following:
The pain may present with one or more of the          . Symptom episodes last  minutes or more,
following:                                               with pain-free intervals; and
. Associated with nausea and vomiting                . Symptoms have occurred on one or more
. Radiates to the back and/or right infra               occasions in the previous  months; and
   subscapular region                                 . The pain is steady and interrupts daily
. Awakens from sleep in the middle of the               activities or requires consultation with a
   night                                                 physician; and
                                                      . There is no evidence of structural
  E1. Functional Gallbladder Disorder
                                                         abnormalities to explain the symptoms.
  Diagnostic criteria
  Must include all of the following:

  . Criteria for functional gallbladder and
     sphincter of Oddi disorder and
  . Gallbladder is present
  . Normal liver enzymes, conjugated
     bilirubin, and amylase/lipase


     
ROME III DIAGNOSTIC CRITERIA                   ROME II DIAGNOSTIC CRITERIA

E2. Functional Biliary Sphincter of Oddi
Disorder
Diagnostic criteria
Must include both of the following:

. Criteria for functional sphincter of Oddi
   disorder
. Normal amylase/lipase
Supportive criterion
Elevated serum transaminases, alkaline
phosphatase, or conjugated bilirubin
temporarily related to at least two pain
episodes

E3. Functional Pancreatic Sphincter of
Oddi Disorder
Diagnostic criteria
Must include both of the following:

. Criteria for functional gallbladder and
   sphincter of Oddi Disorder and
. Elevated amylase/lipase




                                                                      
Gi Functional Dearangements
Gi Functional Dearangements
Gi Functional Dearangements
Gi Functional Dearangements
Gi Functional Dearangements

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  • 1. 8 Κλινικό Θέμα Κλινικό Θέμα Άλγος Δεξιού Υποχονδρίου και Φυσιολογικό Υπερηχοτομογράφημα Ελεύθερη μετάφραση και επιμέλεια: Κων/νος Ι. Ζωγράφος Κλινικό σενάριο ντικός, όπως και στις υπόλοιπες λειτουργικές διαταραχές του πεπτικού συστήματος. Γυναίκα 30 ετών προσέρχεται στο ιατρείο σας αναφέ- ροντας από έτους, διαλείπον, διαξιφιστικό άλγος δεξιού Η συμπτωματολογία υποχονδρίου, με ταυτόχρονη εμφάνιση ναυτίας και ενίο- τε εμέτου. Η διάρκεια του πόνου ποικίλει από 30΄ έως 2 Προεξέχον σύμπτωμα στη δυσκινησία των χοληφόρων εί- ώρες, αντανακλά στη δεξιά ωμική άρθρωση και δε συνδέ- ναι το εντοπισμένο άλγος στο δεξιό υποχόνδριο. Τα χα- εται με τις κενώσεις ή τη φυσική άσκηση. Σε επανειλημ- ρακτηριστικά του έχουν καθοριστεί από τα κριτήρια Ρώ- μένες επισκέψεις της ασθενούς στα επείγοντα περιστατι- μης ΙΙΙ. Ο πόνος είναι διαλείπων, αντανακλά στη δεξιά ωμι- κά, ο αιματολογικός έλεγχος (ηπατική βιοχημεία, αμυλά- κή άρθρωση ή την πλάτη, συχνά συνοδεύεται από ναυτία ση κ.λπ.) καθώς και το υπερηχοτομογράφημα άνω κοιλί- ή έμετο και συνήθως είναι μεταγευματικός. ας ήταν φυσιολογικά. Πρόσφατη ενδοσκόπηση ανωτέρου Ίκτερος ή πυρετός δεν υπάρχουν και η κλινική εξέταση εί- πεπτικού δεν ανέδειξε παθολογία. ναι συνήθως χωρίς ευρήματα εκτός από κάποια ήπια ευαι- σθησία κατά την ψηλάφηση του δεξιού υποχονδρίου. Το πρόβλημα Φυσιολογικό υπερηχοτομογράφημα και αιματολογικός Διαγνωστική προσπέλαση έλεγχος. Προέρχεται το άλγος από τα χοληφόρα; Ίσως Διαγνωστικά εργαλεία πρώτης γραμμής, η γαστροσκόπη- πρόκειται για αλιθιασική χολοκυστοπάθεια αφού αποκλει- ση, η MRCP, και το EUS με τη γνωστή ειδικότητα και ευαι- σθούν πρώτα το πεπτικό έλκος, η χοληδοχολιθίαση και σθησία που τα διακρίνει. μικρολιθίαση, οι νεοπλασίες χοληφόρων και παγκρέατος, Στο πρόσφατο παρελθόν μια σειρά δοκιμασιών μάς έδι- το ευερέθιστο έντερο και το μυοσκελετικό άλγος. νε τη δυνατότητα εκτίμησης της συσπαστικής λειτουργί- Η παθοφυσιολογία της αλιθιασικής χολοκυστοπάθειας ας της χοληδόχου κύστεως. Όπως η αναπαραγωγή πόνου δεν είναι πλήρως κατανοητή. Πιθανές θεωρίες είναι η πα- μετά από χορήγηση CCK, η χολοκυστογραφία με CCK, η ρεμπόδιση στη ροή της χολής από τη χοληδόχο κύστη, δι- διενέργεια υπερηχοτομογραφήματος, και η μέτρηση του αταραχές κινητικότητας αυτής, έλλειψη συντονισμού με- όγκου της χοληδόχου με παράλληλη χορήγηση CCK ή ταξύ χοληδόχου κύστεως και σφιγκτήρα του Οddi και, τέ- γεύματος. Παρόλα αυτά, η άμεση εξάρτηση του αποτε- λος, η σπλαγχνική υπερευαισθησία. λέσματος από τον εκτελούντα την εξέταση, καθώς και η Διαταραχή κινητικότητας της χοληδόχου παρατηρείται χαμηλή ευαισθησία και ειδικότητα που διαθέτουν τις καθι- μετά από εναπόθεση κρυστάλλων χοληστερόλης επί του στούν πλέον μη αξιόπιστες. τοιχώματός της, ασθενής ανταπόκριση στη χολοκυστοκι- Η πλέον χρησιμοποιούμενη δοκιμασία για τη διάγνωση της νίνη (CCK) και, τέλος, συγγενείς ανωμαλίες αυτής. Ο ρό- αλιθιασικής χολοκυστοπάθειας είναι το σπινθηρογράφη- λος της σπλαγχνικής υπερευαισθησίας είναι εξίσου σημα- μα χοληφόρων (99mtechnetium- labeled hepatoiminodiacetic endo_no12 c.indd 8 13/5/2009 3:30:07 µµ
  • 2. 9 acid, 99mHIDA). Το iminodiacetic acid προσλαμβάνεται από Ίσως η πιο αξιόπιστη διαδικασία είναι εκείνη την οποία πε- το ήπαρ και απεκκρίνεται με τη χολή. Το κλάσμα εξώθησης ριγράφουν οι Krishnamurthy και συνεργάτες, κατά τους της χοληδόχου κύστης εκτιμάται μετά από χορήγηση CCK, οποίους η χορήγηση είναι 3΄ σε διάστημα 30΄και 60΄. ενώ ο βαθμός κένωσης εξαρτάται από τη δόση και το ρυθ- Η απουσία, λοιπόν, προτύπου τρόπου εκτέλεσης της δο- μό χορήγησης. Χαμηλό κλάσμα εξώθησης είναι ενδεικτικό κιμασίας έχει σαν αποτέλεσμα τη μη κοινά αποδεκτή και δυσλειτουργίας. Ορισμένοι ασθενείς εμφανίζουν αναπαρα- ίσως τη λανθασμένη αξιολόγηση του αποτελέσματος. Οι Κλινικό Θέμα γωγή των συμπτωμάτων κατά τη διάρκεια της δοκιμασίας, περισσότερες δημοσιεύσεις για την εκτίμηση των αποτε- και αυτό αποτελεί προγνωστικό στοιχείο για καλή ανταπό- λεσμάτων αναφέρουν παρουσία δυσλειτουργίας όταν το κριση στην πιθανή χολοκυστεκτομή. Όταν η HIDA επιβε- κλάσμα εξώθησης της χοληδόχου είναι <35-40%. Επίσης βαιώσει τη δυσλειτουργία της χοληδόχου η χειρουργική υπερσυσταλτικότητα της χοληδόχου (>85%) μπορεί να αντιμετώπιση είναι πολύ πιθανή. Εκτιμάται, ότι τις δύο τε- προκαλέσει αναπαραγωγή παρόμοιων συμπτωμάτων. λευταίες δεκαετίες η αύξηση του αριθμού των χολοκυστε- κτομών ίσως οφείλεται στις αυξανόμε- Η ειδικότητα της χολοκυστογραφίας για τη διάγνωση της νες θετικές δοκιμασίες. Αρκετές μελέ- δυσλειτουργίας της χοληδόχου δεν εί- τες προσπάθησαν να αναδείξουν τα ναι 100%. Αρκετές άλλες νοσολογικές πιθανά οφέλη μιας τέτοιας απόφασης Παρά την ευρεία χρήση οντότητες όπως η παχυσαρκία, ο σακ- εκ μέρους του θεράποντος ιατρού, της χολοκυστογραφίας χαρώδης διαβήτης, η κύηση, η κοιλιο- αλλά η αναδρομικότητα των μελετών κάκη, καθώς και λήψη φαρμάκων (ανα- για τη διάγνωση στολείς διαύλων ασβεστίου, οπιοειδή, καθώς και ο μικρός αριθμός των συμ- μετεχόντων ασθενών καθιστά τα απο- της αλιθιασικής αντιχολινεργικά) μπορούν να προκαλέ- τελέσματά τους χαμηλής αξιοπιστί- χολοκυστοπάθειας σουν παρόμοια εικόνα. ας. Όμως μια προοπτική μελέτη των υπάρχουν αρκετά Yap et al ξεκάθαρα υποστηρίζει τη χει- ΜΕΤΑ ΤΗ ρουργική αντιμετώπιση του προβλή- αδιευκρίνιστα σημεία ΧΟΛΟΚΥΣΤΕΚΤΟΜΗ… ματος. Ασθενείς με θετική HIDA για για τη διαδικασία Παρά την ΄΄θετικά προσκείμενη΄΄ βι- αλιθιασική χολοκυστοπάθεια (κλάσμα εκτέλεσης της βλιογραφία ως προς τη θεραπευτι- εξώθησης < 40%) διακρίθηκαν σε δυο κή αποτελεσματικότητα της χολοκυ- υποομάδες, χειρουργηθέντες (n =11) δοκιμασίας τα οποία στεκτομής, υπάρχουν ακόμη αρκετά και μη (n = 10). Χρόνος παρακολού- μειώνουν την αναπάντητα ερωτήματα. Οι ασθενείς θησης 34 μήνες. Από την πρώτη ομά- αξιοπιστία της με δυσλειτουργία της χοληδόχου δα 10 είχαν πλήρη ύφεση συμπτωμά- έχουν μερική και όχι πλήρη ύφεση των, και 1 μερική^ εν αντιθέσει, όλοι οι των συμπτωμάτων μετά το χειρουρ- ασθενείς της δεύτερης ομάδας παρέ- γείο. Οι λόγοι παραμένουν αδιευκρί- μειναν συμπτωματικοί, και 2 χειρουργήθηκαν. νιστοι, αλλά πιθανότατα να υπάρχει άλλη γενεσιουρ- Οι Ponsky και συνεργάτες σε μια μετα-ανάλυση 5 μελε- γός αιτία ή η δυσλειτουργία της χοληδόχου να αποτε- τών που αφορούσαν 274 ασθενείς με αλιθιασική χολοκυ- λεί στοιχείο ενός πολυπαραγοντικού συνδρόμου. Υπάρ- στοπάθεια (θετική HIDA) αξιολόγησαν τα οφέλη της χει- χουν ανέκδοτες αναφορές ασθενών με φυσιολογική δο- ρουργικής θεραπείας. Βελτίωση των συμπτωμάτων εμφά- κιμασία HIDA οι οποίοι είχαν βελτίωση των συμπτωμά- νισε το 98% των χειρουργηθέντων εν αντιθέσει με το 32% των τους μετά τη χολοκυστεκτομή καθώς και αρκετές από την ομάδα εκείνων που αντιμετωπίστηκαν συντηρητι- μελέτες οι οποίες αποκαλύπτουν παρόμοια ανταπόκρι- κά. Πλήρη ύφεση εμφάνισαν το 74% και 8% αντίστοιχα. ση μετά το χειρουργείο σε ασθενείς με ή χωρίς δυσλει- τουργία της χοληδόχου! Δυστυχώς δεν υπάρχουν ακό- ΑΜΦΙΒΟΛΙΕΣ… μη ασφαλή προγνωστικά στοιχεία πιθανούς ανταπόκρι- σης στη χολοκυστεκτομή ατόμων με επιβεβαιωμένη χο- Παρά την ευρεία χρήση της χολοκυστογραφίας για τη δι- λοκυστοπάθεια. Τέλος, φαίνεται ότι ο βαθμός μείωσης άγνωση της αλιθιασικής χολοκυστοπάθειας υπάρχουν αρ- της συσπαστικής ικανότητας της χοληδόχου, εκτιμώμε- κετά αδιευκρίνιστα σημεία για τη διαδικασία εκτέλεσης νος με τη δοκιμασία HIDA, δε συνδέεται απαραίτητα με της δοκιμασίας τα οποία μειώνουν την αξιοπιστία της. Οι καλύτερη βελτίωση των συμπτωμάτων μετά το χειρουρ- μετρήσεις του κλάσματος εξώθησης της χοληδόχου επη- γείο. ρεάζονται άμεσα από τη δόση, το ρυθμό και τη διάρκεια χορήγησης της CCK. Τυποποιημένος τρόπος διενέργειας Η μακροχρόνια διατήρηση της ανταπόκρισης ίσως είναι της δοκιμασίας, κοινά αποδεκτός, δεν περιγράφεται. Οι ελλιπώς μελετημένη. Το χρονικό διάστημα μελέτης που κατευθυντήριες γραμμές της Εταιρείας Πυρηνικής Ιατρι- αναφέρεται στις περισσότερες μελέτες, συμπεριλαμβα- κής δεν αναφέρουν καμία συγκεκριμένη δόση ή διάρκεια νομένης και του Ponsky, ποικίλει από 9-30 μήνες. Μια χορήγησης της CCK. Στις οδηγίες χρήσης του εμπορικού μελέτη παιδιατρικών ασθενών, με χαμηλό κλάσμα εξώ- προϊόντος Kinevac (sincalide), μια μορφή συνθετικής CCK, θησης, οι οποίοι υποβλήθηκαν σε χολοκυστεκτομή, 1 αναφέρονται τρεις διαφορετικοί τρόποι χορήγησης!!! μήνα μετά είχαν υψηλά ποσοστά ανταπόκρισης. Όμως endo_no12 c.indd 9 13/5/2009 3:30:08 µµ
  • 3. μετά από 2ετή παρακολούθηση τα ποσοστά των ασθε- χου γίνεται βάσει του αποτελέσματος της αναίμακτης νών οι οποίοι παρέμεναν ασυμπτωματικοί ήταν παρόμοια HIDA. Επομένως, σε ασθενή με ακέραια χοληδόχο, η δι- με εκείνα που αντιμετωπίστηκαν συντηρητικά. Η φυσι- άγνωση της αλιθιασικής χολοκυστοπάθειας προηγείται κή εξέλιξη της δυσλειτουργίας της χοληδόχου παραμέ- της ΔΣΟ, θέτοντας έτσι την απόφαση διενέργειας ERCP νει άγνωστη. Παρόλα αυτά σε μια μελέτη αναφέρεται ότι και παράλληλης μανομετρίας (εξετάσεις υψηλής επικιν- ασθενείς με επιβεβαιωμένη δυσλειτουργία (χαμηλό κλά- δυνότητας) σε δεύτερο χρόνο. Ακόμη και σε κέντρα ανα- Κλινικό Θέμα σμα εξώθησης στη δοκιμασία HIDA), εάν υποβληθούν σε φοράς, ο κίνδυνος εμφάνισης επιπλοκών (λοιμώξεις, αι- εκ νέου δοκιμασία μετά από μήνες ή χρόνια, η δυσλει- μορραγία, διάτρηση, παγκρεατίτιδα) με συνοδό νοση- τουργία παραμένει. λεία, μετά από διενέργεια ERCP/ μανομετρίας ανέρχε- ται σε 10-15%. Περιορισμένες αναφορές, αναδρομικού ΔΥΣΛΕΙΤΟΥΡΓΙΑ ΣΦΙΓΚΤΗΡΑ ΤΟΥ ODDI υλικού, που αφορούν τα αποτελέσματα σφιγκτηροτομής Η Δυσλειτουργία του Σφιγκτήρα του Οddi (ΔΣΟ) δυνητι- σε ασθενείς με ΔΣΟ, περιγράφουν ύφεση του άλγους σε κά αποτελεί άλλη μια αιτία εμφάνισης άλγους στην περιο- ποσοστά 40-70%. χή της άνω κοιλίας. Τυπικά εμφανίζεται μετά από χολοκυ- Σε ασθενή με φυσιολογικό κλάσμα εξώθησης χοληδόχου στεκτομή, εντοπίζεται στο δεξιό υποχόνδριο, έχοντας συ- κύστης, μετά από δοκιμασία HIDA, η απόφαση της εμπει- νεχή ή κολικοειδή χαρακτήρα. Αρκετά είναι τα ερωτήματα ρικής χολοκυστεκτομής ή της ERCP, θα πρέπει να λαμβά- τα οποία παραμένουν αναπάντητα, και αφορούν τη σχέση νεται μετά από λεπτομερή ενημέρωση του ασθενούς για ΔΣΟ και δυσλειτουργίας της χοληδόχου: (1) εμφανίζεται τους κινδύνους και τα οφέλη αυτών. η ΔΣΟ σε ασθενείς με άθικτη χοληδόχο κύστη (2) υπάρχει σχέση μεταξύ ΔΣΟ και δυσλειτουργίας της χοληδόχου και ΔΗΜΟΣΙΕΥΜΕΝΕΣ ΚΑΤΕΥΘΥΝΤΗΡΙΕΣ (3) ποιος είναι ο ρόλος της ΔΣΟ και της λανθάνουσας δυ- ΓΡΑΜΜΕΣ σλειτουργίας της χοληδόχου, στην αξιολόγηση και το χει- Η διάσκεψη Ρώμης ΙΙΙ περιγράφει και αποσαφηνίζει τα δι- ρισμό ασθενών με άλγος δεξιού υποχονδρίου και φυσιο- αγνωστικά κριτήρια για τις λειτουργικές διαταραχές της λογικό υπερηχοτομογράφημα; χοληδόχου, αλλά δεν προβαίνει σε κατευθυντήριες γραμ- Υπάρχουν περιορισμένες αναφορές για τη συχνότητα μές για το χειρισμό αυτών των ασθενών. Η Εταιρεία Χει- εμφάνισης ΔΣΟ σε ασθενείς με άθικτη χοληδόχο. Παρό- ρουργικής Πεπτικού Συστήματος, στις κατευθυντήρι- λα αυτά ΔΣΟ έχει πιστοποιηθεί στο 10% ασθενών με συ- ες γραμμές που ανακοίνωσε το 2006 για τη θεραπευτι- μπτωματική χολολιθίαση και στο 50% σε ασθενείς με άλ- κή αντιμετώπιση ασθενών με χολολιθίαση ή χολοκυστοπά- γος δεξιού υποχονδρίου και φυσιολογικό υπερηχοτομο- θεια, συστήνει χολοκυστεκτομή σε ασθενείς με υποτροπι- γράφημα. Παραμένει άγνωστο εάν υπάρχει συσχέτιση άζοντα επεισόδια άλγους προέλευσης χοληφόρων, επιβε- μεταξύ υπερτονίας του Oddi και δυσλειτουργίας της χο- βαιωμένη με χολοκυστογραφία, οριοθετώντας παθολογι- ληδόχου. Σε μια αναδρομική μελέτη, στην οποία συμμε- κό κλάσμα εξώθησης χοληδόχου <30%. n τείχαν 81 ασθενείς με άλγος δεξιού υπο- χονδρίου και φυσιολογική χοληδόχο στο υπερηχοτομογράφημα υποβλήθηκαν σε Άλγος δεξιού υποχονδρίου και φυσιολογικό U/S μανομετρία του Oddi και σε δοκιμασία HIDA. Στους 41 ασθενείς με φυσιολογική Ηπατικά ένζυμα και αμυλάση HIDA το 57% είχαν ΔΣΟ, ενώ στους 40 με παθολογική HIDA 50% είχαν ΔΣΟ. Συμπε- ρασματικά, σε αυτή την ομάδα των ασθε- Παθολογικά Φυσιολογικά Συντηρητική νών, η ΔΣΟ και η δυσλειτουργία της χο- θεραπεία ληδόχου μπορεί να εμφανιστούν ταυτό- χρονα ή ανεξάρτητα η μια από την άλλη. Περαιτέρω διερεύνηση Δοκιμασία HIDA Ασθενείς με άλγος δεξιού υποχονδρίου, και, φυσιολογικό υπερηχοτομογράφημα, Φυσιολογική Παθολογική ηπατικά ένζυμα, αμυλάση και λιπάση δυ- νητικά μπορεί να εμφανίσουν ΔΣΟ. Αξιο- λογώντας έναν ασθενή χωρίς αντικειμενι- ERCP Χολοκυστεκτομή κά στοιχεία χολοπαγκρεατικής νόσου και & με ακέραια τη χοληδόχο κύστη, το ερώτη- Μανομετρία μα που γεννάται είναι κατά πόσον η δια- γνωστική/ θεραπευτική προσέγγιση θα εί- Επιμονή/υποτροπή Ύφεση συμπτωμάτων ναι συντηρητική ή θα πρέπει να προχωρή- συμπτωμάτων σουμε σε περαιτέρω διαγνωστικά και θε- ραπευτικά μέσα επεμβατικού χαρακτήρα. Αλγόριθμος διαγνωστικής προσπέλασης άλγους δεξιού υποχονδρίου Η διάγνωση δυσλειτουργίας της χοληδό- (Πηγή: Clin Gastroenterol Hepatol 2008 AGA Institute) endo_no12 c.indd 10 13/5/2009 3:30:08 µµ
  • 4. 24 ÊáôåõèõíôÞñéåò Ïäçãßåò ÊáôåõèõíôÞñéåò Ïäçãßåò Áðü ôç Ñþìç óôï Los Angeles ÊñéôÞñéá Ñþìçò ÉÉÉ ãéá ôéò ËåéôïõñãéêÝò Äéáôáñá÷Ýò ôïõ Ãáóôñåíôåñéêïý ÓõóôÞìáôïò ãñÜöåé ï Êùíóôáíôßíïò ÆùãñÜöïò Ï äñüìïò ãéá ôç Ñþìç óõíÝ÷éóå ôçí ôç ãáóôñïäùäåêáäáêôõëéêÞ ðåñéï- õðïïìÜäåò ôïõ ÉÂS âáóéæüìåíç óôç ðïñåßá ôïõ ôáîéäåýïíôáò ÄõôéêÜ óôï ÷Þ, ðÜíôá óå áðïõóßá ïðïéáóäÞðïôå óõ÷íüôçôá ôùí êåíþóåùí, ôï ó÷Þìá Los Angeles ôçò Êáëéöüñíéá, ôïí ïñãáíéêÞò, óõóôçìáôéêÞò Þ ìåôáâïëé- ôùí êïðñÜíùí êáé ôá óõìðôþìáôá ÌÜéï ôïõ 2006 ãéá íá áðïêáëýøåé ôá êÞò íüóïõ. Ôá õðüëïéðá óõìðôþìáôá êáôÜ ôçí áöüäåõóç. ¼ìùò, ëüãù ôçò íÝá, áíáèåùñçìÝíá êñéôÞñéá óôï åôÞ- ôá ïðïßá áíáöÝñïíôáí óôá êñéôÞñéá ðïëõðëïêüôçôáò óôçí êëéíéêÞ ðñÜîç óéï DDW. Óôï ßäñõìá Ñþìçò óõììå- Ñþìçò ÉÉ äåí êáëýðôïíôáé ðëÝïí áðü áëëÜ êáé ëüãù åëëåßøåùò êáëÜ ôåê- ôÝ÷ïõí ðÜíù áðü 100 äéåèíåßò åéäéêïß ôçí ´´ïìðñÝëá´´ ôçò ëåéôïõñãéêÞò äõ- ìçñéùìÝíùí âéâëéïãñáöéêþí äåäïìÝ- óå èÝìáôá ëåéôïõñãéêþí äéáôáñá÷þí óðåøßáò. Åðßóçò äçìéïõñãïýíôáé äýï íùí, ç äçìéïõñãßá-áíáèåþñçóç ôùí ôïõ ãáóôñåíôåñéêïý óõóôÞìáôïò õðïïìÜäåò, ïìÜäá ó÷åôéæüìåíç ìå õðïïìÜäùí ôïõ IBS âáóßóôçêå ìüíï (Functional Gastrointestinal Disorders, ãåýìá êáé ïìÜäá ó÷åôéæüìåíç ìå Üë- óôç óýóôáóç ôùí êïðñÜíùí, êÜôé ôï FGID). ãïò, äßíïíôáò ôéò ïíïìáóßåò óýíäñï- ïðïßï õðïóôçñßæïõí êáé ðñüóöáôåò ìá åðéãáóôñéêïý Üëãïõò êáé ìåôáãåõ- ìåëÝôåò. Ïé ìåßæïíåò áëëáãÝò ïé ïðïßåò Ýëáâáí ìáôéêü distress óýíäñïìï. Ðñïò ôï ÷þñá óôá áíáèåùñçìÝíá êñéôÞñéá Ç íÝá ðñïôåéíüìåíç ôáîéíüìçóç ç ðáñüí ôá íÝá áõôÜ óýíäñïìá ðñÝðåé Ñþìçò ÉÉÉ, ðåñéëáìâÜíïõí: ïðïßá âáóßóôçêå ìüíï óôç óýóôáóç íá ÷ñçóéìïðïéïýíôáé ìüíï ãéá åñåõ- 1. Åðáíáðñïóäéïñéóìü ôïõ áðáéôïý- ôùí êïðñÜíùí åßíáé: IBS ìå äõóêïéëé- íçôéêïýò óêïðïýò êáé ü÷é óôçí êëéíéêÞ ìåíïõ ÷ñïíéêïý ðëáéóßïõ ãéá ôçí üôçôá, IBS ìå äéÜññïéá, ìéêôü IBS êáé ðñÜîç, ìÝ÷ñé ôçí ðëÞñç áîéïëüãçóÞ ðëÞñç ôáýôéóç ôïõ óõìðôþìáôïò ÉÂS áêáèüñéóôï. ôïõò. ìå ôá äéáãíùóôéêÜ êñéôÞñéá. Ðëçñüôçôá êáé ðñþéìïò êïñåóìüò Ïé áóèåíåßò ìå ìéêôü IBS åìöáíßæïõí 2. ÁëëáãÝò óôá êñéôÞñéá ôáîéíüìçóçò áíôéðñïóùðåýïõí ìéá îå÷ùñéóôÞ óêëçñÜ êáé ðïëôþäç êüðñáíá áíÜ (ï ìçñõêáóìüò ðëÝïí áíÞêåé óôéò ïìÜäá, äéáöïñåôéêÞ áðü ôç íáõôßá ðåñéüäïõò ùñþí Þ çìåñþí, åíþ ïé ãáóôñïäùäåêáäáêôõëéêÝò ëåéôïõñ- êáé ôïí Ýìåôï. ÕðÜñ÷ïõí ðëÝïí äýï áóèåíåßò ìå åíáëëáãÝò ôùí ´´óõíç- ãéêÝò äéáôáñá÷Ýò, êáé ôï óýíäñïìï äéáöïñåôéêÝò ïíôüôçôåò -óýíäñïìá- èåéþí´´ ôïõ åíôÝñïõ áëëÜæïõí õðï- êïéëéáêïý ëåéôïõñãéêïý Üëãïõò ôá ïðïßá êáèïñßóôçêáí óôá êñéôÞñéá ïìÜäá áíÜ ðåñéüäïõò åâäïìÜäùí Þ áðïôåëåß îå÷ùñéóôÞ êáôçãïñßá êáé Ñþìçò ÉÉÉ: ôï óýíäñïìï êõêëéêþí åìÝ- êáé ìçíþí. Ôï ó÷Þìá ôùí êïðñÜíùí ü÷é ëåéôïõñãéêÞ äéáôáñá÷Þ ôïõ ðá- ôùí êáé ç ÷ñüíéá éäéïðáèÞò íáõôßá. êáèïñßæåôáé óýìöùíá ìå ôçí êëßìáêá ÷Ýïò åíôÝñïõ). Bristol óõó÷åôßæoíôÜò ôï ìå ôï ÷ñüíï 3. ÐñïóèÞêç ðáéäéáôñéêþí êáôçãïñé- Ôþñá, üóïí áöïñÜ ôá êñéôÞñéá ôùí äéÝëåõóÞò ôïõò áðü ôï Ýíôåñï. þí. ëåéôïõñãéêþí äéáôáñá÷þí ôïõ ðá÷Ý- 4. Áîéïëüãçóç ôçò óýóôáóçò-ìïñöÞò ïò åíôÝñïõ êáé ôùí õðïïìÜäùí ôïõ Êëåßíïíôáò, ç óçìáíôéêüôåñç áëëáãÞ ôùí êïðñÜíùí ãéá ôïí êáèïñéóìü óõíäñüìïõ åõåñÝèéóôïõ åíôÝñïõ, ïé ç ïðïßá Ýëáâå ÷þñá óôéò ëåéôïõñãéêÝò ôùí õðïïìÜäùí ôïõ óõíäñüìïõ êõñéüôåñåò áëëáãÝò ðïõ åðéôåëÝóèç- äéáôáñá÷Ýò ôçò ÷ïëçäü÷ïõ êýóôåùò åõåñÝèéóôïõ åíôÝñïõ (äéÜññïéá Þ êáí åßíáé: êáé ôïõ óöéãêôÞñá ôïõ Oddi, åßíáé üôé äõóêïéëéüôçôá). 1. ÅéóáãùãÞ ôçò óõ÷íüôçôáò ôùí óõ- ðëÝïí, äåí áíáöÝñåôáé ãåíéêÜ óáí 5. Áõóôçñüôåñá êñéôÞñéá ãéá ôç äõ- ìðôùìÜôùí óáí ´´êáôþöëé´´ ãéá íá ëåéôïõñãéêÝò äéáôáñá÷Ýò ôùí ÷ïëç- óëåéôïõñãßá ôçò ÷ïëçäü÷ïõ êýóôå- óõíáíôÞóïõí ôá êñéôÞñéá (ð.÷. ôñåéò öüñùí, áëëÜ åöåîÞò ëáìâÜíåôáé õð´ ùò êáé ôïõ óöéêôÞñá ôïõ Oddi. ïé ðåñéóóüôåñåò çìÝñåò ôï ìÞíá ãéá üøéí ôï áíôßóôïé÷ï áíáôïìéêü óçìåßï Óôá êñéôÞñéá Ñþìçò ÉÉÉ áíáèåùñÞèçêå ôïõò ôñåéò ôåëåõôáßïõò ìÞíåò) ãÝíåóçò ôïõ ðñïâëÞìáôïò. åðßóçò êáé ï ïñéóìüò ôçò ëåéôïõñãéêÞò 2. ÄéÜñêåéá óõìðôùìÜôùí (ìåéþèçêáí Åðßóçò ï üñïò billiary- like syndrome äõóðåøßáò äßíïíôáò íÝåò äéáóôÜóåéò. ðåñéóóüôåñï áðü Ýîé ìÞíåò) áíáðôý÷èçêå óõíáéíåôéêÜ: ¸ôóé ðëÝïí óáí ëåéôïõñãéêÞ äõóðå- 3. ÐëÞñçò äéÜêñéóç ôùí õðïïìÜäùí 1. ¢ëãïò åíôïðéóìÝíï óôï åðéãÜóôñéï øßá ïñßæåôáé, Ýíá Þ ðåñéóóüôåñá óõ- ôïõ åõåñÝèéóôïõ åíôÝñïõ. Þ/ êáé óôï äåîéü Üíù ôåôáñôçìüñéï ìðôþìáôá ôá ïðïßá åìöáíßæïíôáé áðü Ç åðéôñïðÞ Ñþìçò ÉÉ äçìéïýñãçóå 2. ÕðïôñïðéÜæïíôá åðåéóüäéá åìöá- endo_no4e.indd 24 18/4/2007 2:48:17 ìì
  • 5. 25 íéæüìåíá óå äéáöïñåôéêÜ ÷ñïíéêÜ ôçôá ôïõ áóèåíïýò Þ ôïí ïäçãïýí 1. Óõíäõáóìüò ìå íáõôßá Þ Ýìåôï äéáóôÞìáôá (ü÷é êáèçìåñéíÜ) óôï íïóïêïìåßï. 2. Áêôéíïâïëåß óôçí ðåñéï÷Þ ôçò ðëÜ- 3. Åðåéóüäéá Üëãïõò äéÜñêåéáò 30 ëå- ôçò Þ óôç äåîéÜ ùìïðëáôéáßá ÷þñá ðôþí Þ êáé ðåñéóóüôåñï, ìå áõîá- Åíéó÷õôéêÜ óõìðôþìáôá åßíáé åÜí ï êáé ðüíïò åìöáíéóôåß ìå Ýíá áðü ôá ðá- ÊáôåõèõíôÞñéåò Ïäçãßåò íüìåíç Ýíôáóç (ìÝóç Þ õøçëÞ) ôá 3. ÍõêôåñéíÞ áöýðíéóç. ïðïßá åðçñåÜæïõí ôçí êáèçìåñéíü- ñáêÜôù: ÐÉÍÁÊÁÓ 1: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÇ ËÅÉÔÏÕÑÃÉÊÇ ÄÕÓÐÅØÉÁ ÄéÜñêåéá óõìðôùìÜôùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, êáé ôá ïðïßá åìöáíßæïíôáé ìå Ýíá Þ ðåñéóóüôåñá áðü ôá ðáñáêÜôù: * ÌåôáãåõìáôéêÞ ðëçñüôçôá * Åðéãáóôñéêü Üëãïò * Ðñþéìïò êïñåóìüò * Åðéãáóôñéêüò êáýóïò ÊÁÉ * ÊáíÝíá óôïé÷åßï éóôéêÞò âëÜâçò (óõìðåñéëáìâáíïìÝíçò ôçò åíäïóêüðçóçò ôïõ áíùôÝñïõ ðåðôéêïý) ôï ïðïßï íá äéêáéïëïãåß ôá óõìðôþìáôá. ÐÉÍÁÊÁÓ 2: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÅÐÉÃÁÓÔÑÉÊÏÕ ÁËÃÏÕÓ ÄéÜñêåéá ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, ìå ÏËÁ ôá ðáñáêÜôù: Ðüíïò êáé êáýóïò ôá ïðïßá: * ÅíáëëÜóóïíôáé * Åíôïðßæïíôáé óôï åðéãÜóôñéï, ôïõëÜ÷éóôïí ìÝóçò åíôÜóåùò, ìéá öïñÜ ôçí åâäïìÜäá Êáé Ï×É 1. ãåíéêåõìÝíá Þ åíôïðéóìÝíá óå Üëëç ðåñéï÷Þ ôçò êïéëßáò Þ ôïõ èþñáêá 2. íá åðÝñ÷åôáé áíáêïýöéóç ìå ôçí áöüäåõóç Þ ôçí åêôüíùóç áåñßùí 3. íá ðëçñïß ôá êñéôÞñéá ãéá äéáôáñá÷Ýò ôçò ÷ïëçäü÷ïõ êýóôçò Þ ôïõ óöéãêôÞñá ôïõ Oddi ÐÉÍÁÊÁÓ 3: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÌÅÔÁÃÅÕÌÁÔÉÊÏ DISTRESS ÓÕÍÄÑÏÌÏ ÔïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò 6 ôåëåõôáßïõò ìÞíåò, ìå Ýíá áðü ôá ðáñáêÜôù: * ÌåôáãåõìáôéêÝò åíï÷ëÞóåéò 1. ïé ïðïßåò åìöáíßæïíôáé ìåôÜ áðü êáíïíéêïý ìåãÝèïõò ãåýìáôá 2. ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò ôçí åâäïìÜäá ¹ * Ðñþéìïò êïñåóìüò 1. ðïõ åìðïäßæåé ôçí ïëïêëÞñùóç åíüò êáíïíéêïý ìåãÝèïõò ãåýìáôïò 2. êáé åìöáíßæåôáé ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò ôçí åâäïìÜäá ÐÉÍÁÊÁÓ 4: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÊÕÊËÉÊÙÍ ÅÌÅÔÙÍ ÔïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, ìå: * ÔõðéêÜ åðåéóüäéá åìÝôùí ìå ïîåßá Ýíáñîç êáé äéÜñêåéá 1 åâäïìÜäáò ôïõëÜ÷éóôïí * 3 Þ ðåñéóóüôåñá îå÷ùñéóôÜ åðåéóüäéá ôá ðñïçãïýìåíá Ýôç * Áðïõóßá íáõôßáò êáé åìÝôùí ìåôáîý ôùí åðåéóïäßùí Åíéó÷õôéêÜ êñéôÞñéá: Éóôïñéêü êåöáëáëãßáò, ôýðïõ çìéêñáíßáò Þ ïéêïãåíåéáêïý éóôïñéêïý çìéêñáíßáò. ÐÉÍÁÊÁÓ 5: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÇ ×ÑÏÍÉÁ ÉÄÉÏÐÁÈÇ ÍÁÕÔÉÁ ÄéÜñêåéá åðåéóïäßùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç 6 ìÞíåò ðñéí. * Íáõôßá ç ïðïßá åìöáíßæåôáé ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò êáôÜ ôç äéÜñêåéá ôçò åâäïìÜäáò ôïõò 3 ôåëåõôáßïõò ìÞíåò * Äåí áêïëïõèåß óõíÞèùò Ýìåôïò * Áðïõóßá ðáèïëïãéêþí åõñçìÜôùí óôçí åíäïóêüðçóç ôïõ áíùôÝñïõ ðåðôéêïý Þ ìåôáâïëéêÞò íüóïõ ç ïðïßá äéêáéïëïãåß ôç íáõôßá ÐÉÍÁÊÁÓ 6: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÅÕÅÑÅÈÉÓÔÏÕ ÅÍÔÅÑÏÕ ÄéÜñêåéá åðåéóïäßùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç 6 ìÞíåò ðñéí, áðïôåëïýìåíá áðü õðïôñïðéÜæïíôá êïéëéáêÜ Üëãç Þ äõóöïñßá**, óå óõíäõáóìü ìå äýï Þ ðåñéóóüôåñá áðü ôá áêüëïõèá: * ¾öåóç óõìðôùìÜôùí ìå ôéò êåíþóåéò êáé /Þ * Ýíáñîç ôùí óõìðôùìÜôùí ðïõ óõíäõÜæåôáé ìå áëëáãÞ ôçò óõ÷íüôçôáò ôùí êåíþóåùí êáé /Þ * Ýíáñîç ôùí óõìðôùìÜôùí ðïõ óõíäõÜæåôáé ìå áëëáãÞ ôçò ìïñöÞò ôùí êïðñÜíùí. ** Ùò äõóöïñßá ðåñéãñÜöåôáé ç äõóÜñåóôç áßóèçóç êáé ü÷é ðüíïò endo_no4e.indd 25 18/4/2007 2:48:18 ìì
  • 6. Appendix A Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders 
  • 7.  Appendix A: Rome III Diagnostic Criteria for FGIDs A. Functional Esophageal Disorders A1. Functional Heartburn Diagnostic criteria* Must include all of the following: . Burning retrosternal discomfort or pain . Absence of evidence that gastroesophageal acid reflux is the cause of the symptom . Absence of histopathology-based esophageal motility disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis A2. Functional Chest Pain of Presumed Esophageal Origin Diagnostic criteria* Must include all of the following: . Midline chest pain or discomfort that is not of burning quality . Absence of evidence that gastroesophageal reflux is the cause of the symptom . Absence of histopathology-based esophageal motility disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis A3. Functional Dysphagia Diagnostic criteria* Must include all of the following: . Sense of solid and/or liquid foods sticking, lodging, or passing abnormally through the esophagus . Absence of evidence that gastroesophageal reflux is the cause of the symptom . Absence of histopathology-based esophageal motility disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis A4. Globus Diagnostic criteria* Must include all of the following: . Persistent or intermittent, nonpainful sensation of a lump or foreign body in the throat . Occurrence of the sensation between meals . Absence of dysphagia or odynophagia . Absence of evidence that gastroesophageal reflux is the cause of the symptom . Absence of histopathology-based esophageal motility disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis
  • 8. Appendix A: Rome III Diagnostic Criteria for FGIDs  B. Functional Gastroduodenal Disorders B1. FUNCTIONAL DYSPEPSIA Diagnostic criteria* Must include: . One or more of the following: a. Bothersome postprandial fullness b. Early satiation c. Epigastric pain d. Epigastric burning AND . No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis B1a. Postprandial Distress Syndrome Diagnostic criteria* Must include one or both of the following: . Bothersome postprandial fullness, occurring after ordinary-sized meals, at least several times per week . Early satiation that prevents finishing a regular meal, at least several times per week * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis Supportive criteria . Upper abdominal bloating or postprandial nausea or excessive belching can be present . Epigastric pain syndrome may coexist B1b. Epigastric Pain Syndrome Diagnostic criteria* Must include all of the following: . Pain or burning localized to the epigastrium of at least moderate severity, at least once per week . The pain is intermittent . Not generalized or localized to other abdominal or chest regions . Not relieved by defecation or passage of flatus . Not fulfilling criteria for gallbladder and sphincter of Oddi disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis Supportive criteria . The pain may be of a burning quality, but without a retrosternal component . The pain is commonly induced or relieved by ingestion of a meal, but may occur while fasting . Postprandial distress syndrome may coexist
  • 9.  Appendix A: Rome III Diagnostic Criteria for FGIDs B2. BELCHING DISORDERS B2a. Aerophagia Diagnostic criteria* Must include all of the following: . Troublesome repetitive belching at least several times a week . Air swallowing that is objectively observed or measured * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis B2b. Unspecified Excessive Belching Diagnostic criteria* Must include all of the following: . Troublesome repetitive belching at least several times a week . No evidence that excessive air swallowing underlies the symptom * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis B3. NAUSEA AND VOMITING DISORDERS B3a. Chronic Idiopathic Nausea Diagnostic criteria* Must include all of the following: . Bothersome nausea occurring at least several times per week . Not usually associated with vomiting . Absence of abnormalities at upper endoscopy or metabolic disease that explains the nausea * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis B3b. Functional Vomiting Diagnostic criteria* Must include all of the following: . On average one or more episodes of vomiting per week . Absence of criteria for an eating disorder, rumination, or major psychiatric disease according to DSM-IV . Absence of self-induced vomiting and chronic cannabinoid use and absence of abnormalities in the central nervous system or metabolic diseases to explain the recurrent vomiting * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis
  • 10. Appendix A: Rome III Diagnostic Criteria for FGIDs  B3c. Cyclic Vomiting Syndrome Diagnostic criteria Must include all of the following: . Stereotypical episodes of vomiting regarding onset (acute) and duration (less than one week) . Three or more discrete episodes in the prior year . Absence of nausea and vomiting between episodes Supportive criterion History or family history of migraine headaches B4. Rumination Syndrome in Adults Diagnostic criteria Must include both of the following: . Persistent or recurrent regurgitation of recently ingested food into the mouth with subsequent spitting or remastication and swallowing . Regurgitation is not preceded by retching Supportive criteria . Regurgitation events are usually not preceded by nausea . Cessation of the process when the regurgitated material becomes acidic . Regurgitant contains recognizable food with a pleasant taste C. Functional Bowel Disorders C1. Irritable Bowel Syndrome Diagnostic criterion* Recurrent abdominal pain or discomfort** at least  days/month in the last  months associated with two or more of the following: . Improvement with defecation . Onset associated with a change in frequency of stool . Onset associated with a change in form (appearance) of stool * Criterion fulfilled for the last  months with symptom onset at least  months prior to diagnosis ** “Discomfort” means an uncomfortable sensation not described as pain. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least  days a week during screening evaluation is recommended for subject eligibility. C2. Functional Bloating Diagnostic criteria* Must include both of the following: . Recurrent feeling of bloating or visible distension at least  days/month in the last  months . Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel syndrome, or other functional GI disorder * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis
  • 11.  Appendix A: Rome III Diagnostic Criteria for FGIDs C3. Functional Constipation Diagnostic criteria* . Must include two or more of the following: a. Straining during at least % of defecations b. Lumpy or hard stools in at least % of defecations c. Sensation of incomplete evacuation for at least % of defecations d. Sensation of anorectal obstruction/blockage for at least % of defecations e. Manual maneuvers to facilitate at least % of defecations (e.g., digital evacuation, support of the pelvic floor) f. Fewer than three defecations per week . Loose stools are rarely present without the use of laxatives . Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis C4. Functional Diarrhea Diagnostic criterion* Loose (mushy) or watery stools without pain occurring in at least % of stools * Criterion fulfilled for the last  months with symptom onset at least  months prior to diagnosis C5. Unspecified Functional Bowel Disorder Diagnostic criterion* Bowel symptoms not attributable to an organic etiology that do not meet criteria for the previously defined categories * Criterion fulfilled for the last  months with symptom onset at least  months prior to diagnosis D. Functional Abdominal Pain Syndrome D. Functional Abdominal Pain Syndrome Diagnostic criteria* Must include all of the following: . Continuous or nearly continuous abdominal pain . No or only occasional relationship of pain with physiological events (e.g., eating, defecation, or menses) . Some loss of daily functioning . The pain is not feigned (e.g., malingering) . Insufficient symptoms to meet criteria for another functional gastrointestinal disorder that would explain the pain * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis
  • 12. Appendix A: Rome III Diagnostic Criteria for FGIDs  E. Functional Gallbladder and Sphincter of Oddi Disorders E. Functional Gallbladder and Sphincter of Oddi Disorders Diagnostic criteria Must include episodes of pain located in the epigastrium and/or right upper quadrant and all of the following: . Episodes lasting  minutes or longer . Recurrent symptoms occurring at different intervals (not daily) . The pain builds up to a steady level . The pain is moderate to severe enough to interrupt the patient’s daily activities or lead to an emergency department visit . The pain is not relieved by bowel movements . The pain is not relieved by postural change . The pain is not relieved by antacids . Exclusion of other structural disease that would explain the symptoms Supportive criteria The pain may present with one or more of the following: . Associated with nausea and vomiting . Radiates to the back and/or right infra subscapular region . Awakens from sleep in the middle of the night E1. Functional Gallbladder Disorder Diagnostic criteria Must include all of the following: . Criteria for functional gallbladder and sphincter of Oddi disorder . Gallbladder is present . Normal liver enzymes, conjugated bilirubin, and amylase/lipase E2. Functional Biliary Sphincter of Oddi Disorder Diagnostic criteria Must include both of the following: . Criteria for functional gallbladder and sphincter of Oddi disorder . Normal amylase/lipase Supportive criterion Elevated serum transaminases, alkaline phosphatase, or conjugated bilirubin temporarily related to at least two pain episodes E3. Functional Pancreatic Sphincter of Oddi Disorder Diagnostic criteria Must include both of the following: . Criteria for functional gallbladder and sphincter of Oddi disorder and . Elevated amylase/lipase
  • 13.  Appendix A: Rome III Diagnostic Criteria for FGIDs F. Functional Anorectal Disorders F1. Functional Fecal Incontinence Diagnostic criteria* . Recurrent uncontrolled passage of fecal material in an individual with a developmental age of at least  years and one or more of the following: a. Abnormal functioning of normally innervated and structurally intact muscles b. Minor abnormalities of sphincter structure and/or innervation c. Normal or disordered bowel habits, (i.e., fecal retention or diarrhea) d. Psychological causes AND . Exclusion of all the following: a. Abnormal innervation caused by lesion(s) within the brain (e.g., dementia), spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple sclerosis), or as part of a generalized peripheral or autonomic neuropathy (e.g., due to diabetes) b. Anal sphincter abnormalities associated with a multisystem disease (e.g., scleroderma) c. Structural or neurogenic abnormalities believed to be the major or primary cause of fecal incontinence * Criteria fulfilled for the last  months F2. FUNCTIONAL ANORECTAL PAIN F2a. Chronic Proctalgia Diagnostic criteria* Must include all of the following: . Chronic or recurrent rectal pain or aching . Episodes last  minutes or longer . Exclusion of other causes of rectal pain such as ischemia, inflammatory bowel disease, cryptitis, intramuscular abscess, anal fissure, hemorrhoids, prostatitis, and coccygodynia * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis Chronic proctalgia may be further characterized into levator ani syndrome or unspecified anorectal pain based on digital rectal examination. F2a.1. Levator Ani Syndrome Diagnostic criterion Symptom criteria for chronic proctalgia and tenderness during posterior traction on the puborectalis
  • 14. Appendix A: Rome III Diagnostic Criteria for FGIDs  F2a.2. Unspecified Functional Anorectal Pain Diagnostic criterion Symptom criteria for chronic proctalgia but no tenderness during posterior traction on the puborectalis F2b. Proctalgia Fugax Diagnostic criteria Must include all of the following: . Recurrent episodes of pain localized to the anus or lower rectum . Episodes last from seconds to minutes . There is no anorectal pain between episodes For research purposes criteria must be fulfilled for  months; however, clinical diagnosis and evaluation may be made prior to  months. F3. Functional Defecation Disorders Diagnostic criteria* . The patient must satisfy diagnostic criteria for functional constipation** . During repeated attempts to defecate must have at least two of the following: a. Evidence of impaired evacuation, based on balloon expulsion test or imaging b. Inappropriate contraction of the pelvic floor muscles (i.e., anal sphincter or puborectalis) or less than % relaxation of basal resting sphincter pressure by manometry, imaging, or EMG c. Inadequate propulsive forces assessed by manometry or imaging * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis ** Diagnostic criteria for functional constipation: () Must include two or more of the following: (a) Straining during at least % of defeca- tions, (b) Lumpy or hard stools in at least % of defecations, (c) Sensation of incomplete evacuation for at least % of defecations, (d) Sensation of anorectal obstruction/blockage for at least % of defecations, (e) Manual maneuvers to facilitate at least % of defeca- tions (e.g., digital evacuation, support of the pelvic floor), (f ) Fewer than three defecations per week. () Loose stools are rarely present without the use of laxatives. () Insufficient criteria for irritable bowel syndrome. F3a. Dyssynergic Defecation Diagnostic criterion Inappropriate contraction of the pelvic floor or less than % relaxation of basal resting sphincter pressure with adequate propulsive forces during attempted defecation F3b. Inadequate Defecatory Propulsion Diagnostic criterion Inadequate propulsive forces with or without inappropriate contraction or less than % relaxation of the anal sphincter during attempted defecation
  • 15.  Appendix A: Rome III Diagnostic Criteria for FGIDs G. Childhood Functional GI Disorders: Infant/Toddler G1. Infant Regurgitation Diagnostic criteria Must include both of the following in otherwise healthy infants 3 weeks to 12 months of age: . Regurgitation two or more times per day for  or more weeks . No retching, hematemesis, aspiration, apnea, failure to thrive, feeding or swallowing difficulties, or abnormal posturing G2. Infant Rumination Syndrome Diagnostic criteria Must include all of the following for at least 3 months: . Repetitive contractions of the abdominal muscles, diaphragm, and tongue . Regurgitation of gastric content into the mouth, which is either expectorated or rechewed and reswallowed . Three or more of the following: a. Onset between  and  months b. Does not respond to management for gastroesophageal reflux disease, or to anticholinergic drugs, hand restraints, formula changes, and gavage or gastrostomy feedings c. Unaccompanied by signs of nausea or distress d. Does not occur during sleep and when the infant is interacting with individuals in the environment G3. Cyclic Vomiting Syndrome Diagnostic criteria Must include both of the following: . Two or more periods of intense nausea and unremitting vomiting or retching lasting hours to days . Return to usual state of health lasting weeks to months G4. Infant Colic Diagnostic criteria Must include all of the following in infants from birth to 4 months of age: . Paroxysms of irritability, fussing or crying that starts and stops without obvious cause . Episodes lasting  or more hours/day and occurring at least  days/wk for at least  week . No failure to thrive G5. Functional Diarrhea Diagnostic criteria Must include all of the following: . Daily painless, recurrent passage of three or more large, unformed stools . Symptoms that last more than  weeks . Onset of symptoms that begins between  and  months of age . Passage of stools that occurs during waking hours . There is no failure-to-thrive if caloric intake is adequate
  • 16. Appendix A: Rome III Diagnostic Criteria for FGIDs  G6. Infant Dyschezia Diagnostic criteria Must include both of the following in an infant less than 6 months of age . At least  minutes of straining and crying before successful passage of soft stools . No other health problems G7. Functional Constipation Diagnostic criteria Must include one month of at least two of the following in infants up to 4 years of age: . Two or fewer defecations per week . At least one episode/week of incontinence after the acquisition of toileting skills . History of excessive stool retention . History of painful or hard bowel movements . Presence of a large fecal mass in the rectum . History of large diameter stools which may obstruct the toilet Accompanying symptoms may include irritability, decreased appetite, and/or early satiety. The accompanying symptoms disappear immediately following passage of a large stool. H. Childhood Functional GI Disorders: Child/Adolescent H1. VOMITING AND AEROPHAGIA H1a. Adolescent Rumination Syndrome Diagnostic criteria* Must include all of the following: . Repeated painless regurgitation and rechewing or expulsion of food that a. begin soon after ingestion of a meal b. do not occur during sleep c. do not respond to standard treatment for gastroesophageal reflux . No retching . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject’s symptoms * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis H1b. Cyclic Vomiting Syndrome Diagnostic criteria Must include both of the following: . Two or more periods of intense nausea and unremitting vomiting or retching lasting hours to days . Return to usual state of health lasting weeks to months H1c. Aerophagia Diagnostic criteria* Must include at least two of the following: . Air swallowing . Abdominal distention due to intraluminal air . Repetitive belching and/or increased flatus * Criteria fulfilled at least once per week for at least  months prior to diagnosis
  • 17.  Appendix A: Rome III Diagnostic Criteria for FGIDs H2. ABDOMINAL PAIN-RELATED FUNCTIONAL GI DISORDERS H2a. Functional Dyspepsia Diagnostic criteria* Must include all of the following: . Persistent or recurrent pain or discomfort centered in the upper abdomen (above the umbilicus) . Not relieved by defecation or associated with the onset of a change in stool frequency or stool form (i.e., not irritable bowel syndrome) . No evidence of an inflammatory, anatomic, metabolic or neoplastic process that explains the subject’s symptoms * Criteria fulfilled at least once per week for at least  months prior to diagnosis H2b. Irritable Bowel Syndrome Diagnostic criteria* Must include both of the following: . Abdominal discomfort** or pain associated with two or more of the following at least % of the time: a. Improvement with defecation b. Onset associated with a change in frequency of stool c. Onset associated with a change in form (appearance) of stool . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject’s symptoms * Criteria fulfilled at least once per week for at least  months prior to diagnosis ** “Discomfort” means an uncomfortable sensation not described as pain. H2c. Abdominal Migraine Diagnostic criteria* Must include all of the following: . Paroxysmal episodes of intense, acute periumbilical pain that lasts for  hour or more . Intervening periods of usual health lasting weeks to months . The pain interferes with normal activities . The pain is associated with  of the following: a. Anorexia b. Nausea c. Vomiting d. Headache e. Photophobia f. Pallor . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process considered that explains the subject’s symptoms * Criteria fulfilled two or more times in the preceding  months
  • 18. Appendix A: Rome III Diagnostic Criteria for FGIDs  H2d. Childhood Functional Abdominal Pain Diagnostic criteria* Must include all of the following: . Episodic or continuous abdominal pain . Insufficient criteria for other FGIDs . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject’s symptoms * Criteria fulfilled at least once per week for at least  months prior to diagnosis H2d1. Childhood Functional Abdominal Pain Syndrome Diagnostic criteria* Must satisfy criteria for childhood functional abdominal pain and have at least 25% of the time one or more of the following: . Some loss of daily functioning . Additional somatic symptoms such as headache, limb pain, or difficulty sleeping * Criteria fulfilled at least once per week for at least  months prior to diagnosis H3. CONSTIPATION AND INCONTINENCE H3a. Functional Constipation Diagnostic criteria* Must include two or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of IBS: . Two or fewer defecations in the toilet per week . At least one episode of fecal incontinence per week . History of retentive posturing or excessive volitional stool retention . History of painful or hard bowel movements . Presence of a large fecal mass in the rectum . History of large diameter stools which may obstruct the toilet * Criteria fulfilled at least once per week for at least  months prior to diagnosis H3b. Nonretentive Fecal Incontinence Diagnostic criteria* Must include all of the following in a child with a developmental age at least 4 years: . Defecation into places inappropriate to the social context at least once per month . No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject’s symptoms . No evidence of fecal retention * Criteria fulfilled for at least  months prior to diagnosis
  • 19.
  • 20. Appendix B Comparison Table of Rome II & Rome III Adult Diagnostic Criteria 
  • 21. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA A. Functional Esophageal Disorders A. Functional Esophageal Disorders A1. Functional Heartburn A4. Functional Heartburn Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include all of the following: in the preceding 12 months of: . Burning retrosternal discomfort or pain . Burning retrosternal discomfort or pain; . Absence of evidence that gastroesophageal and acid reflux is the cause of the symptom . Absence of pathologic gastroesophageal . Absence of histopathology-based reflux, achalasia, or other motility disorder esophageal motility disorders with a recognized pathologic basis. * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis A2. Functional Chest Pain of A3. Functional Chest Pain of Presumed Esophageal Origin Presumed Esophageal Origin Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include all of the following: within the preceding 12 months of: . Midline chest pain or discomfort that is not . Midline chest pain or discomfort that is not of burning quality of burning quality; and . Absence of evidence that gastroesophageal . Absence of pathologic gastroesophageal reflux is the cause of the symptom reflux, achalasia, or other motility disorder . Absence of histopathology-based with a recognized pathologic basis. esophageal motility disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis 
  • 22. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA A3. Functional Dysphagia A5. Functional Dysphagia Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include all of the following: in the preceding 12 months of: . Sense of solid and/or liquid foods sticking, . Sense of solid and/or liquid foods sticking, lodging, or passing abnormally through the lodging, or passing abnormally through the esophagus esophagus; and . Absence of evidence that gastroesophageal . Absence of pathologic gastroesophageal reflux is the cause of the symptom reflux, achalasia, or other motility disorder . Absence of histopathology-based with a recognized pathologic basis. esophageal motility disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis A4. Globus A1. Globus Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include all of the following: in the preceding 12 months of: . Persistent or intermittent, nonpainful . The persistent or intermittent sensation of a sensation of a lump or foreign body in lump or foreign body in the throat; the throat . Occurrence of the sensation between meals; . Occurrence of the sensation between meals . Absence of dysphagia and odynophagia; and . Absence of dysphagia or odynophagia . Absence of pathologic gastroesophageal . Absence of evidence that gastroesophageal reflux, achalasia, or other motility disorder reflux is the cause of the symptom with a recognized pathologic basis (e.g., . Absence of histopathology-based scleroderma of the esophagus). esophageal motility disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis Rome III criteria do not include unspecified A6. Unspecified Functional functional esophageal disorder as in Rome II. Esophageal Disorder At least 12 weeks, which need not be consecutive, in the preceding 12 months of: . Unexplained symptoms attributed to the esophagus that do not fit into the previously described categories; and . Absence of pathologic gastroesophageal reflux, achalasia, or other motility disorder with a recognized pathologic basis. 
  • 23. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA B. Functional Gastroduodenal B. Functional Gastroduodenal Disorders Disorders Note major changes in classification for dyspepsia and nausea and vomiting disorders B1. Functional Dyspepsia B1. Functional Dyspepsia Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include: in the preceding 12 months of: . One or more of the following: . Persistent or recurrent symptoms (pain a. Bothersome postprandial fullness or discomfort centered in the upper b. Early satiation abdomen); c. Epigastric pain . No evidence of organic disease (including d. Epigastric burning at upper endoscopy) that is likely to explain AND the symptoms; and . No evidence of structural disease (including . No evidence that dyspepsia is exclusively at upper endoscopy) that is likely to explain relieved by defecation or associated with the the symptoms onset of a change in stool frequency or stool * Criteria fulfilled for the last  months with form. symptom onset at least  months prior to diagnosis B1a. Ulcer-like dyspepsia Pain centered in the upper abdomen is the B1a. Postprandial Distress Syndrome predominant (most bothersome) symptom. Diagnostic criteria* Must include one or both of the following: B1b. Dysmotility-like dyspepsia An unpleasant or troublesome nonpainful . Bothersome postprandial fullness, sensation (discomfort) centered in the occurring after ordinary-sized meals, at upper abdomen is the predominant least several times per week symptom; this sensation may be . Early satiation that prevents finishing a characterized by or associated with upper regular meal, at least several times per abdominal fullness, early satiety, bloating, week or nausea. * Criteria fulfilled for the last  months with symptom onset at least  months prior to B1c. Unspecified (nonspecific) dyspepsia diagnosis Symptomatic patients whose symptoms Supportive criteria do not fulfill the criteria for ulcer-like or . Upper abdominal bloating or dysmotility-like dyspepsia. postprandial nausea or excessive belching can be present . Epigastric pain syndrome may coexist 
  • 24. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA B1b. Epigastric Pain Syndrome Diagnostic criteria* Must include all of the following: . Pain or burning localized to the epigastrium of at least moderate severity, at least once per week . The pain is intermittent . Not generalized or localized to other abdominal or chest regions . Not relieved by defecation or passage of flatus . Not fulfilling criteria for gallbladder and sphincter of Oddi disorders * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis Supportive criteria . The pain may be of a burning quality, but without a retrosternal component . The pain is commonly induced or relieved by ingestion of a meal, but may occur while fasting . Postprandial distress syndrome may coexist 
  • 25. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA B2. Belching Disorders B2a. Aerophagia B2. Aerophagia Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include all of the following: or more in the preceding 12 months of: . Troublesome repetitive belching at least . Air swallowing that is objectively observed; several times a week and . Air swallowing that is objectively . Troublesome repetitive belching. observed or measured * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis B2b. Unspecified Excessive Belching Diagnostic criteria* Must include all of the following: . Troublesome repetitive belching at least several times a week . No evidence that excessive air swallowing underlies the symptom * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis 
  • 26. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA B3. Nausea and Vomiting Disorders B3a. Chronic Idiopathic Nausea Diagnostic criteria* Must include all of the following: . Bothersome nausea occurring at least several times per week . Not usually associated with vomiting . Absence of abnormalities at upper endoscopy or metabolic disease that explains the nausea * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis B3b. Functional Vomiting B3. Functional Vomiting Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include all of the following: in the preceding 12 months of: . On average one or more episodes of . Frequent episodes of vomiting, occurring vomiting per week on at least three separate days in a week over . Absence of criteria for an eating disorder, three months; rumination, or major psychiatric disease . Absence of criteria for an eating disorder, according to DSM-IV rumination, or major psychiatric disease . Absence of self-induced vomiting and according to DSM-IV; chronic cannabinoid use and absence . Absence of self-induced and medication- of abnormalities in the central nervous induced vomiting; and system or metabolic diseases to explain . Absence of abnormalities in the gut or the recurrent vomiting central nervous system, and metabolic * Criteria fulfilled for the last  months with diseases to explain the recurrent vomiting. symptom onset at least  months prior to diagnosis 
  • 27. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA B3c. Cyclic Vomiting Syndrome Diagnostic criteria Must include all of the following: . Stereotypical episodes of vomiting regarding onset (acute) and duration (less than one week) . Three or more discrete episodes in the prior year . Absence of nausea and vomiting between episodes Supportive criteria History or family history of migraine headaches B4. Rumination Syndrome in Adults A2. Rumination Syndrome Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include both of the following: in the preceding 12 months of: . Persistent or recurrent regurgitation of . Persistent or recurrent regurgitation of recently ingested food into the mouth with recently ingested food into the mouth with subsequent spitting or remastication and subsequent remastication and swallowing; swallowing . Absence of nausea and vomiting; . Regurgitation is not preceded by retching . Cessation of the process when the Supportive criteria regurgitated material becomes acidic; and . Absence of pathologic gastroesophageal . Regurgitation events are usually not reflux, achalasia, or other motility disorder preceded by nausea with a recognized pathologic basis as the . Cessation of the process when the primary disorder. regurgitated material becomes acidic . Regurgitant contains recognizable food with a pleasant taste The Rome III criteria classify rumination as a functional gastroduodenal disorder. In the Rome II classification, rumination was considered a func- tional esophageal disorder. 
  • 28. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA C. Functional Bowel Disorders C. Functional Bowel Disorders C1. Irritable Bowel Syndrome C1. Irritable Bowel Syndrome Diagnostic criterion* At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discom- Recurrent abdominal pain or discomfort** at fort or pain that has two out of three features: least 3 days/month in last 3 months associated with two or more of the following: . Relieved with defecation; and/or . Improvement with defecation . Onset associated with a change in frequency . Onset associated with a change in frequency of stool; and/or of stool . Onset associated with a change in form . Onset associated with a change in form (appearance) of stool. (appearance) of stool Symptoms that Cumulatively Support the Diagnosis of Irritable Bowel Syndrome * Criterion fulfilled for the last  months with symptom onset at least  months prior to – Abnormal stool frequency (for research diagnosis purposes “abnormal” may be defined as **“Discomfort” means an uncomfortable greater than  bowel movements per day sensation not described as pain. and less than  bowel movements per week); In pathophysiology research and clinical trials, – Abnormal stool form (lumpy/hard or loose/ a pain/discomfort frequency of at least  days watery stool); a week during the screening evaluation is recommended for subject eligibility. – Abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); – Passage of mucus; – Bloating or feeling of abdominal distension. C2. Functional Bloating C2. Functional Abdominal Bloating Diagnostic criteria* At least 12 weeks, which need not be consecutive, Must include both of the following: in the preceding 12 months of: . Recurrent feeling of bloating or visible . Feeling of abdominal fullness, bloating, or distension at least  days/month in the last visible distension; and  months . Insufficient criteria for a diagnosis of . Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel functional dyspepsia, irritable bowel syndrome, or other functional disorder. syndrome, or other functional GI disorder * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis 
  • 29. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA C3. Functional Constipation C3. Functional Constipation Diagnostic criteria* At least 12 weeks, which need not be consecutive, in the preceding 12 months of two or more of: . Must include two or more of the following: a. Straining during at least % of . Straining > / of defecations; defecations . Lumpy or hard stools > / of defecations; b. Lumpy or hard stools in at least % of . Sensation of incomplete evacuation > / of defecations defecations; c. Sensation of incomplete evacuation for . Sensation of anorectal obstruction/blockage at least % of defecations > / of defecations; d. Sensation of anorectal obstruction/ . Manual maneuvers to facilitate > / of blockage for at least % of defecations defecations (e.g., digital evacuation, support e. Manual maneuvers to facilitate at of the pelvic floor); and/or least % of defecations (e.g., digital . <  defecations per week. evacuation, support of the pelvic floor) Loose stools are not present, and there are f. Fewer than three defecations per week insufficient criteria for IBS. . Loose stools are rarely present without the use of laxatives . Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis C4. Functional Diarrhea C4. Functional Diarrhea Diagnostic criterion* At least 12 weeks, which need not be consecutive, in the preceding 12 months of: Loose (mushy) or watery stools without pain occurring in at least % of stools . Loose (mushy) or watery stools * Criterion fulfilled for the last  months with . Present > / of the time; and symptom onset at least  months prior to . No abdominal pain. diagnosis C.5. Unspecified Functional Bowel C5. Unspecified Functional Bowel Disorder Disorder Diagnostic criterion* Bowel symptoms not attributable to an Bowel symptoms in the absence of organic organic etiology that do not meet criteria for disease that do not fit into the previously the previously defined categories defined categories of functional bowel disorders. * Criterion fulfilled for the last  months with symptom onset at least  months prior to diagnosis 
  • 30. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA D. Functional Abdominal Pain D. Functional Abdominal Pain Syndrome D. Functional Abdominal Pain D1. Functional Abdominal Syndrome Pain Syndrome Diagnostic criteria* At least 6 months of: Must include all of the following: . Continuous or nearly continuous . Continuous or nearly continuous abdominal pain; and abdominal pain . No or only occasional relationship of pain . No or only occasional relationship of pain with physiological events (e.g., eating, with physiological events (e.g., eating, defecation, or menses); and defecation, or menses) . Some loss of daily functioning; and . Some loss of daily functioning . The pain is not feigned (e.g., malingering), . The pain is not feigned (e.g., malingering) and . Insufficient symptoms to meet criteria for . Insufficient criteria for other functional another functional gastrointestinal disorder gastrointestinal disorders that would that would explain the pain explain the abdominal pain. * Criteria fulfilled for the last  months with symptom onset at least  months prior to diagnosis The Rome III Criteria do not include Unspecified D2. Unspecified Functional Functional Abdominal Pain Abdominal Pain This is functional abdominal pain that fails to reach criteria for functional abdominal pain syndrome. 
  • 31. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA E. Functional Gallbladder and E. Functional Disorders of the Biliary Sphincter of Oddi Disorders Tract and the Pancreas E. Functional Gallbladder and E1. Gallbladder Dysfunction Sphincter of Oddi Disorders Episodes of severe steady pain located in the epi- Diagnostic criteria gastrium and right upper quadrant, and all of the Must include episodes of pain located in the following: epigastrium and/or right upper quadrant . Symptom episodes last  minutes or more, and all of the following: with pain-free intervals; . Episodes lasting  minutes or longer . Symptoms have occurred on one or more . Recurrent symptoms occurring at different occasions in the previous  months; intervals (not daily) . The pain is steady and interrupts daily . The pain builds up to a steady level activities or requires consultation with a . The pain is moderate to severe enough to physician; interrupt the patient’s daily activities or lead . There is no evidence of structural to an emergency department visit abnormalities to explain the symptoms; . The pain is not relieved by bowel . There is abnormal gallbladder functioning movements with regard to emptying. . The pain is not relieved by postural change . The pain is not relieved by antacids E2. Sphincter of Oddi Dysfunction . Exclusion of other structural disease that Episodes of severe steady pain located in the epi- would explain the symptoms gastrium and right upper quadrant, and all of the Supportive criteria following: The pain may present with one or more of the . Symptom episodes last  minutes or more, following: with pain-free intervals; and . Associated with nausea and vomiting . Symptoms have occurred on one or more . Radiates to the back and/or right infra occasions in the previous  months; and subscapular region . The pain is steady and interrupts daily . Awakens from sleep in the middle of the activities or requires consultation with a night physician; and . There is no evidence of structural E1. Functional Gallbladder Disorder abnormalities to explain the symptoms. Diagnostic criteria Must include all of the following: . Criteria for functional gallbladder and sphincter of Oddi disorder and . Gallbladder is present . Normal liver enzymes, conjugated bilirubin, and amylase/lipase 
  • 32. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA E2. Functional Biliary Sphincter of Oddi Disorder Diagnostic criteria Must include both of the following: . Criteria for functional sphincter of Oddi disorder . Normal amylase/lipase Supportive criterion Elevated serum transaminases, alkaline phosphatase, or conjugated bilirubin temporarily related to at least two pain episodes E3. Functional Pancreatic Sphincter of Oddi Disorder Diagnostic criteria Must include both of the following: . Criteria for functional gallbladder and sphincter of Oddi Disorder and . Elevated amylase/lipase 