avilash case

1. SIGNIFICANCE OF SERUM ALBUMIN AS A
PREDICTOR OF POST OPERATIVE MORBIDITY IN
PATIENTS REQUIRING EMERGENCY ABDOMINAL
SURGERY- An Observational Prospective Study
Candidate- Dr Avilash Pradhan
1st year post graduate trainee, Dept Of General Surgery
Guide- Dr Swapan Chowdhury ; Associate Professor, Department of
General Surgery
Co Guide- Dr P K Mishra; Professor Paediatric Surgery JIMSH

2. OBJECTIVE OF RESEARCH:
• Primary objective-to To assess the post operative morbidity with relation to pre operative albumin , in
patients undergoing emergency abdominal surgery.
• Secondary Objective- to assess preoperative albumin as a part of nutritional status of all patients to be
treated surgically
• 1 Post operative wound complications like
i) Surgical site infection
ii)Wound dehiscence
2 Systemic complications like
i) Respiratory tract infection
ii) Urinary Tract Infection
iii) Anastomotic Leak

3. METHODOLOGY
1. Study design – Observational prospective study
2. Study timelines- June 2023- December 2024
3. Place of study- Department of General Surgery JIMSH, Buita, Budge-Budge, Kolkata 700137
4. Period of study- 18 months
5. Study population – All patients admitted in General Surgery IPD requiring emergency abdominal surgery.
6. Sample size- 96
considering 95% confidence interval with absolute error of 10% and proportion of morbidity to be 48.9% used from a previous study done by
Kumar SV et al sample size calculated to be 96. by using the formula 1.96²(pq)/l² . 96 patients will be taken in this study
7.Case control : Not required
8.Inclusion and Exclusion Criteria:
• INCLUSION- Patients above 12 years old requiring emergency exploratory laparotomy under the department of General Surgery
and Paediatric Surgery JIMSH
• EXCLUSION – Patients with chronic disease like liver failure , nephrotic syndrome, chronic kidney disease
• paediatric abdominal emergencies <12yrs
• patients who did not give consent.

4. Study variables:
• Name:
• Age:
• Sex:
• Hospital No:
• MRD No:
• Occupation:
• Address:
• Religion:
• Chief complaints:
• History of present illness:
• Past history:
• Personal history:
• Menstrual history (in women):
• Family history:
• Socioeconomic history: based on revised kuppu swamy scale.
• Immunization history:
• Drug history:
• Allergy history:
• GENERAL-PHYSICAL EXAMINATION:
• General appearance:
• Mental status:
• Decubitus:
• Built: Poor/ moderate/ well/ obese
• Body weight and BMI
• Nutrition: poor/ moderate/ well
• Pallor:
• Icterus:
• Cyanosis:
• Clubbing:
• Oedema:
• Lymphadenopathy:
• Skin and subcutaneous tissue:
• Oral cavity:
• Tongue:

5. • PER ABDOMINAL EXAMINATION:
• Inspection:
• Palpation:
• Percussion:
• Auscultation:
• OTHER SYSTEMIC EXAMINATION:
• Cardiovascular system:
• Respiratory system:
• Central Nervous system:
• GCS:
• PROVISIONAL DIAGNOSIS:
• DIFFERTIAL DIAGNOSIS:
• INVESTIGATIONS:
• Blood routine investigations:
• Pathological: CBC
• Biochemistry:
• RBS, Blood Urea/Serum Creatinine:
• Liver Function Test:
• SGOT/SGPT
• Bilirubin levels including direct and
indirect
• Total Protein levels
• Albumin
• Globulin
• A:G Ratio
• Radiological:
• USG and Xray of abdomen-
• Chest X-Ray (Postero- anterior view)-
• Cardiological:
• 12 - Lead electrocardiogram-
• Echocardiography
• Others – CT scan with/without contrast,
MRI(as Required)
• FINAL DIAGNOSIS:

6. • PRE-OPERATIVE MEASURES:
• All patients will be given prophylactic IV antibiotics
• OPERATIVE NOTE:
. IV Fluids
• Incision:
• Operative Findings:
• Operation proposed:
• Operation executed:
• Intra-operative complications: if any
• POST OPERATIVE PERIOD:
• Measurement of body temperature
• Pulse
• Blood pressure
• Respiratory rate
• Examination of chest
• Symptoms and signs of urinary tract infection.
. Urine Culture
Chest Xray-will be done in patients complaining cough and
pneumonia like symptoms
. Ultrasound of whole Abdomen/CT scan- if we are suspecting a
postoperative complication
Liver function test-inclusive of albumin Postoperatively on
(POD 0,3,7)
• POST OPERATIVE COMPLICATIONS IF
ANY AND ITS MANAGEMENT:
• haemorrhage
• SSI
• Wound Dehiscence
• Lower respiratory tract infection
• Urinary tract infection
• Anastomotic leak-intra peritoneal collection
• Others
FOLLOW UP:
• DAY O
• DAY 3
• DAY 7
. DAY 21

7. CONSENT FORM
PART 1 of 2
INFORMATION FOR PARTICIPANTS OF THE STUDY
PARTICIPANT INFORMATION SHEET
Title of the project- Significance of serum albumin as a predictor of postoperative morbidity in patients requiring emergency abdominal
surgery in a tertiary care Hospital of West Bengal
Name of the investigator/guide/Co guide –Dr Avilash Pradhan/ Dr. Swapan Choudhury Associate Professor General Surgery/Dr P K
Mishra Professor Paediatric Surgery
Purpose of this project/study- to assess the post operative morbidity in relation to pre operative albumin, in patients undergoing emergency
abdominal surgery in the department of Surgery
Procedure/methods of the study- An observational prospective study
Expected duration of the subject participation- June 2023 to December 2024
The benefits to be expected from the research to the participant or to others and the post-trial responsibilities of the investigator-
consider correcting nutrition of the patient to prevent post operative morbidity. Albumin could be used as a predictor of morbidity in
predicting post operative outcome of the patients requiring abdominal surgeries, post-trial responsibilities includes the improvement of
global nutrition of the patients to minimize post operative morbidity and mortality.
Any risks expected from the study to the participant- no
Maintenance of confidentiality of records-yes
Provision of free treatment for research related injury-yes

8. - Compensation of the participants not only for disability or death resulting from such injury but also for unforeseeable risks-Since it is an
observational prospective study any risk or study related injury involving the patient is not expected, hence compensation issue does not
arise.
- Freedom to withdraw from the study at any time during the study period without the loss of benefits that the participant would otherwise
be entitled- yes
- Possible current and future uses of the biological material and of the data to be generated from the research and if the material is likely to
be used for secondary purposes or would be shared with others-yes
- Address and telephone number of the investigator and co-investigator/guide-
- Student Investigator Dr Avilash Pradhan
• Office address – C
• Mobile no- 8013483500
• Email- avilash.a.pradhaan@gmail.com
- Name of Guide Dr Swapan Choudhury
• Office address – Jagannath Gupta Institute Of medical Science and Hospital
• Mobile no- 8420289898
• Email – dr_schoudhury21@rediffmail.com
- Name Of Co Guide- Prof Dr P K Mishra
• Ofiice Address- Jagannath Gupta Institute Of medical Science and Hospital
• Mobile No-
• Email-
Signature Of Investigator

9. • CONSENT FORM
• PART 2 of 2- Participant consent form
• Protocol Study number:
• Patient identification number for this study:
• Title of the project: Significance of serum albumin as a predictor of post operative morbidity in patients requiring emergency abdominal surgery
• Name of Principal investigator: Dr Avilash Pradhan PGT
• Tel. No(s).8013483500
• The contents of the information sheet dated that was provided have been read carefully by me / explained in detail to me, in a language that I comprehend, and I have fully understood the
contents. I confirm that I have had the opportunity to ask questions.
• The nature and purpose of the study and its potential risks / benefits and expected duration of the study, and other relevant details of the study have been explained to me in detail. I understand that my
participation is voluntary and that I am free to withdraw from the study at any time, without giving any reason, without my medical care or legal right beingaffected.
• I agree to take part in the above study
• Signatures / Left Thumb Impression)
• Date:
• Place:
• i understand that the information collected about me from my participation in this research and sections of any of my medical notes may be looked at by responsible individuals from JIMSH, Budge budge. I
give permission for these individuals to have access to my records.
• I agree to take part in the above study
• --------------------------------------------
• (Signatures / Left Thumb Impression)
• Name of Participant: Son/Daughter/spouse of:
• Complete postal address:
• This is to certify that the above consent has been obtained in my presence.
• -------------------------------------------- ………………………………….
• Signatures of the Principal Investigator Signatures of the Witness

10. CONSENT FORM (for participants less than18 years of age)
• PART 2 of 2- Parent/Legally accepted representative(LAR)
• Participant’s Name:
• Address:
• Parent/ LAR’ s name:
• Title of the project: Significance of serum albumin as a predictor of post operative morbidity in patients requiring emergency abdominal surgery
• The details of the study have been provided to me in writing and explained to me in my own language. I confirm that I have understood the above study
and had the opportunity to ask questions. I understand that my child/ward’s participation in the study is voluntary and that I am free to withdraw my
child/ward at any time, without giving any reason, without the medical care that will normally be provided by the hospital being affected. I agree not to
restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s). I have been given an information
sheet giving details of the study. I fully consent for the participation of my child/ward in the above study.
• Assent of child/ward obtained (for participants 12 to 18 years of age)
• Signature of the parent/LAR: Date:
• Signature of the witness: Date:
• Signature of the investigator: Date _____

11. CONSENT FORM
I, Mr. / Mrs. ___________________________ have been informed about all the aspects of the study, by the investigator verbally in a language known to me. I have been given the
opportunity to discuss all aspects of the study, to ask questions and hereby consent to participation in the study.
I understand that my participation in this study is voluntary, and I am free to withdraw at any time, without having to give any reason and without my rights and privileges being
affected.
I understand that my data will be kept confidential, but the individuals appointed by principal investigator, ethics committee of the institution where the study is being conducted and the
regulatory authority will have access to the records both in respect of the current study and future research that may be conducted in relation to it. Even if I withdraw, I agree to this
access. However, I understand that my identity will not be revealed, and confidentiality of the information will be maintained.
I agree to take part in this study voluntarily.
Signature of participant / Left thumb impression of participant:
Date:

12. আমাকে ___________________________গকেষণার সমস্ত দিে সম্পকেে অেদিত েরা িক়েকে|
এটি গকেষণাোরী দ্বারা আমার জানা ভাষা়ে মমৌদিে ভাকে জানাকনা িক়েকে। আমাকে গকেষণার
সমস্তদিে দনক়ে আক াচনা েরার ,প্রশ্ন জজজ্ঞাসা েরার এেং এর মাধ্যকম গকেষণাকত সম্মদত
মিও়োর সুক াগ মিও়ো িক়েকে।
আদম েুঝকত পাদর ম এই গকেষণা়ে আমার অংশগ্রিণ মেচ্ছাকত এেং আদম মোনও োরণ োডাই
এেং আমার অদধ্োর এেং সুক াগ-সুদেধ্াগুদ ক্ষদতগ্রস্থ িও়ো োডাই ম কোনও সম়ে প্রতযািার
েরকত োধ্ীন।
আদম েুঝকত পাদর ম এইগকেষণা়ে ম পরীক্ষা মনও়ো িকে তাকত জদডত মোনও উকেিক াগয
ঝুুঁ দে মনই।
আদম েুঝকত পাদর ম আমার তথ্য মগাপন রািা িকে তকে প্রধ্ান গকেষেেতত েে দন ুক্ত েযজক্তগণ,ম
প্রদতষ্ঠাকনর গকেষণা পদরচাদ ত িকচ্ছ এেং সরোদর েতত েপকক্ষর দন ুক্ত েম ে
চারী েতেমান অধ্য়েন
এেং ভদেষযকতর গকেষণার মক্ষকে া এটির সাকথ্ পদরচাদ ত িকত পাকর উভ়েই মরেকডে অযাকেস
পাকে। আদম প্রতযািার েরক ও আদম এই অনুমদত দিজচ্ছ। তকে আদম েুঝকত পাদর ম আমার
পদরচ়ে প্রোদশত িকেনা এেং তকথ্যর মগাপনী়েতা েজা়ে থ্ােকে।
আদম এোকডদমে উকেকশয এই অধ্য়েকনর ফক উত্পন্ন মোনও তথ্য সীমােদ্ধ না রািকত সম্মত
।
আদম মেচ্ছা়ে এই গকেষণা়ে অংশ দনকত সম্মত ।
অংশগ্রিণোরীর োক্ষর / োম থ্াম্বইকেশন

13. सहमति - पत्र
मुझे ___________________________ को अध्ययन क
े सभी पहलुओं,क
े बारे में जांचकर्ाा द्वारा मेरे द्वारा
ज्ञार्भाषा में मौखिक रूप से बर्ाया गया है। मुझे परीक्षण क
े सभी पहलुओं पर चचाा करने ,सवाल पूछने
और परीक्षण में भाग लेने क
े ललए सहमलर् देने का अवसर लदया गया है।
मैं समझर्ा हं लक इस अध्ययन में मेरी भागीदारी स्वैखिक है और मैं लकसी भी समय वापस लेने क
े ललए
स्वर्ंत्र हं ,लबना लकसी कारण क
े और मेरे अलिकारों और लवशेषालिकार प्रभालवर् हुए लबना ।
मैं समझर्ा हं लक इस अध्ययन में परीक्षण में कोई महत्वपूणा जोखिम शालमल नहीं है ।
मैं समझर्ा हं लक मेरे डेटा को गोपनीय रिा जाएगा , लेलकन संस्था क
े प्रमुि अन्वेषक , नैलर्कर्ा सलमलर्
द्वारा लनयुक्त व्यखक्त जहां अध्ययन लकया जा रहा है और लनयमक प्रालिकारी को वर्ामान अध्ययन और
भलवष्य क
े इस क
े संबंि में अनुसंिान में ररकॉडा र्क पहुंच होगी इसकी सहमलर् ललए सहमर् हं ।
अगर मैं अपना सहमलर्, अध्ययन से वापस लेर्ा हं र्ो भी मैं इस पहुंच से सहमर् हं । हालांलक मैं समझर्ा
हं लक मेरी पहचान उजागर नहीं की जाएगी और सूचना की गोपनीयर्ा बनाए रिी जाएगी ।
मैं इस अध्ययन से उत्पन्न लकसी भी डेटा को शैक्षलणक उद्देश्यक
े ललए प्रलर्बंलिर् नहीं करने क
े ललए सहमर्
हं ।
मैं स्वेिा से इस अध्ययन में भाग लेने क
े ललए सहमर् हं ।
अध्ययन में भाग लेने वाले अन्वेषक का हस्ताक्षर क
े हस्ताक्षर / बाएं अंगूठे का लनशान :
र्ारीि: