3. ARTICLES
FIGURE 1
Protocol design.
Functional constipation is a common tive in clearing RFI for many as 95% of to fulfill 1 of the other Rome III crite-
condition in childhood, with a world- patients.3,10 Youssef et al3 performed ria for functional constipation present
wide prevalence of 7% to 30%.1 Approx- an uncontrolled trial in which possible for 8 weeks, that is, (1) defecation
imately 30% to 75% of children with adverse events (eg, fecal inconti- frequency of 3 times per week, (2)
long-standing functional constipa- nence) were not documented, how- 1 fecal incontinence episode per
tion have abdominal fecal impaction ever, and Candy et al10 applied an un- week, (3) history of retentive posturing
and/or rectal fecal impaction (RFI) on clear definition for fecal impaction. or excessive volitional stool retention,
physical examination, which results in We hypothesized that enemas and (4) history of painful or hard defeca-
severe fecal incontinence in 90% of the orally administered laxatives would be tion, and (5) history of large-diameter
patients.2–4 Fecal impaction has been equally effective in removing a fecal stools that may obstruct the toilet.14
defined as a large fecal mass, noted mass from the rectum but enemas Patients with a history of colorectal
through either abdominal palpation or would be less well tolerated and co- surgery or an organic cause for consti-
rectal examination, which is unlikely to lonic transit time (CTT) would improve pation were excluded.
be passed on demand.5 It is important during disimpaction. Therefore, the
to assess the presence of RFI in chil- aim of our study was to evaluate the Protocol
dren with constipation, because dis- efficacy and tolerability of enemas ver- The protocol design is depicted in Fig 1.
impaction should be achieved before sus high doses of orally administered
initiation of maintenance therapy.6,7 PEG for disimpaction in children with Definition of RFI and Successful
If initial disimpaction is omitted, functional constipation and RFI. Fur- Disimpaction
then oral laxative treatment may re- thermore, we aimed to evaluate the ef-
sult paradoxically in an increase of Before study entry, the presence of RFI
fect of disimpaction on bowel habits
fecal incontinence attributable to was evaluated by the physician per-
and CTT.11–13
overflow diarrhea. forming a rectal digital examination.
RFI was defined as a large amount of
Despite the lack of scientific data, ene- METHODS
hard stool in the rectum (fecaloma).
mas have long been advocated as the
Study Setting and Design Successful disimpaction was defined
best first-line treatment for severe RFI.
Between February 2005 and July 2008, as the absence of fecaloma on rectal
It often is assumed, however, that chil-
a randomized, controlled trial was examination. If patients were too
dren strongly dislike enema adminis-
tration.3,8 Manual evacuation of feces conducted at a tertiary hospital frightened to undergo a second rectal
under general anesthesia may de- (Emma Children’s Hospital, Amster- examination, then abdominal radiog-
crease the stress for the child; how- dam, Netherlands). The hospital’s raphy was performed for assessment
ever, one study described the risk of medical ethics committee approved of RFI.
structural injury to the anal sphincter the research protocol. All parents and
children 12 years of age provided Standardized Questionnaire and
after manual disimpaction in consti-
pated adults.9 Manual disimpaction written consent. Bowel Diary
not only contributes to sphincter The standardized questionnaire at in-
weakness in some patients but also is Subjects take included questions regarding
an expensive procedure.9 Two studies Patients were eligible if they were be- medical history, age at onset of defeca-
showed that oral administration of a tween 4 and 16 years of age and dem- tion problems, current bowel habits,
high dose of polyethylene glycol (PEG) onstrated evidence of RFI on rectal ex- and laxative use. The standardized
for 3 to 6 consecutive days was effec- amination. Furthermore, they needed bowel diary recorded defecation and
PEDIATRICS Volume 124, Number 6, December 2009 e1109
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4. fecal incontinence frequency, consis- parents at the end of the disimpaction tested by using Yates’ continuity-
tency of stools, and abdominal pain. week. corrected 2 statistics or Fisher’s ex-
act test, depending on cell frequen-
CTT Assessments Outcome Measurements cies. Statistical significance was
Whole and segmental CTTs were deter- The primary outcome was successful defined as P .05. All analyses were
mined by using the method described disimpaction. Secondary outcome performed by using the statistical soft-
by Arhan et al.11 Radiograph localiza- measures of defecation and fecal in- ware package SPSS 14.0 (SPSS Inc, Chi-
tion of markers was based on the iden- continence frequency, abdominal cago, IL).
tification of bony landmarks and gas- pain, watery stools, CTT values, and
eous outlines, as described by Arhan et child’s behavior scores were calcu- RESULTS
al.11 Patients ingested 1 capsule with lated for children who completed the Baseline Findings
10 radioopaque markers (Sitzmarks study protocol.
[Bipharma, Weesp, Netherlands]) for 6 Between February 2005 and July 2008,
consecutive days. Subsequently, an ab- Adequacy of Sample 627 patients with constipation visited
dominal radiograph was obtained on A total sample size of 90 was required our outpatient clinic (Fig 2), of whom
day 7 for counting of the markers to achieve 80% power, at a significance 90 participated. Forty-six and 44 pa-
present in the colon and rectosig- level of .05, to detect a 20% difference tients were assigned randomly to re-
moid bowel segment. The number of in proportions of successful disimpac- ceive enemas and PEG, respectively. As
markers multiplied by 2.4 deter- tion between treatment groups with a depicted in Table 1, baseline charac-
mined the total CTT (in hours). A total 2-sided 2 test, with the assumption teristics were balanced between the 2
CTT of 62 hours, an ascending co- that 75% of children who received oral treatment groups. Before study enroll-
lon CTT of 18 hours, a descending laxative treatment would be treated ment, 39% (n 18) of the enema
colon CTT of 20 hours, and a successfully. group and 36% (n 16) of the PEG
rectosigmoid segment CTT of 34 group had a history of enema use (P
hours were considered delayed.11 Data Analysis and Interpretation .83). A total of 10 patients dropped out
Patients’ characteristics were docu- (Fig 2). In the enema group, dropout
Disimpaction and Maintenance mented descriptively. Data for all pa- was attributable to receipt of 5 ene-
Treatment tients, including those who did not mas instead of 6 (n 1), hospitaliza-
One group received rectal enemas complete the 2 study periods accord- tion during the study (n 1), non-
(dioctylsulfosuccinate sodium; Klyx ing to the protocol, were analyzed ac- compliance in recording bowel
[Pharmachemie, Haarlem, the Nether- cording to an intention-to-treat ap- diaries (n 1), or missed appoint-
lands]) once daily for 6 consecutive proach, to describe the primary ments at the outpatient clinic (n
days (60 mL for children 6 years of outcome variable. Comparison of the 2). The patient who was hospitalized
age and 120 mL for children 6 years proportions of successful disimpac- during the study required clinical
of age). The other group received tion between the 2 groups was per- oral lavage with Klean-prep (Norgine,
orally administered PEG 3350 with formed by using the 2 test. Differ- Amsterdam, the Netherlands; 1.5 L/day
electrolytes (Movicolon [Norgine, Am- ences in defecation and fecal 88.5 g of PEG) for 7 consecutive days
sterdam, the Netherlands], 1.5 g/kg incontinence frequency were analyzed and therefore was excluded from anal-
per day) for 6 consecutive days. Main- by using Student’s t test. For CTT anal- ysis. In the PEG group, dropout was at-
tenance treatment was started after 6 ysis, differences in CTT values within tributable to administration of a low
days of disimpaction treatment and groups, before disimpaction versus af- PEG dose (0.5 g/kg per day instead of
consisted of orally administered PEG ter 6 days of disimpaction, were as- 1.5 g/kg per day) (n 3), noncompli-
3350 with electrolytes (Movicolon, 0.5 sessed with a paired-sample t test; dif- ance in recording bowel diaries (n
g/kg per day) for 2 weeks (follow-up ferences between the groups after 6 1), and failure to return for follow-up
period). days of disimpaction were assessed evaluation (n 1).
through analysis of covariance, to ad-
Behavior Score Assessments just for scores at baseline. Segmental Enemas Versus Oral PEG
A child’s behavior questionnaire con- CTTs (delayed or not delayed) were Treatment
taining 7 questions evaluating the as- evaluated by using 2 statistics. Differ- Successful disimpaction was achieved
sociation between behavior and laxa- ences in the presence (yes or no) of for 37 patients (80%) from the enema
tive treatment was completed by all abdominal pain or watery stools were group and 30 patients (68%) from the
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5. ARTICLES
FIGURE 2
Consolidated Standards of Reporting Trials diagram.
PEG group (P .28) (Fig 2). Three pa- with PEG maintenance treatment. Pa- enced failure of a second intensive
tients from the enema group with tients who initially experienced failure oral or rectal disimpaction regimen
unsuccessful initial disimpaction of oral disimpaction treatment (n 9) were admitted to the clinic for colonic
achieved successful disimpaction af- achieved successful disimpaction with lavage (Fig 2).
ter extension of the rectal treatment addition of 1 enema daily for a total of 3
with 1 enema for 1 day in combination days in 4 cases. Patients who experi- Bowel Habits and Symptoms
As shown in Tables 1 and 2, a signifi-
TABLE 1 Baseline Characteristics With Inclusion and Exclusion of Dropouts
cant increase in defecation frequency
Total Patients Patients With Follow-up Data
was achieved in both groups after the
disimpaction week. The frequency of
Enema PEG P Enema PEG P
fecal incontinence was significantly
N 46 44 41 39
Male, n 29 31 27 27 lower in the enema group (P .001)
Age, mean SD, y 7.9 2.9 7.2 2.6 7.9 2.9 7.2 2.6 during disimpaction but not at the
Defecation frequency, mean 1.9 2.4 1.5 1.8 .46 2.1 2.5 1.4 1.7 .18 follow-up evaluation (P .58). Watery
SD, times per wk
Symptom duration, mean 5.2 3.3 4.7 2.8 .29 5.4 3.3 4.8 2.9 .42
stools were reported more frequently
SD, mo in the PEG group during disimpaction
Presence of abdominal fecal 17 29 .01 15 27 .003 (10 vs 28 patients; P .001) and at the
mass, n
follow-up evaluation (4 vs 13 patients;
Daytime fecal incontinence 15.7 13.1 16.6 12.4 .13 14.9 14.0 12.0 10.7 .30
frequency, mean SD, P .03).
times per wk
Nighttime fecal incontinence 1.2 2.4 1.0 2.4 .70 1.0 2.1 1.1 2.6 .85 CTT Results
frequency, mean SD,
times per wk Two patients in the enema group and 6
Abdominal pain, n 22 28 .37 21 27 .34 patients in the PEG group were not
Watery stools, n 2 4 .18 1 4 .12 able to ingest the radioopaque mark-
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6. TABLE 2 Bowel Habits and Gastrointestinal Symptoms After 6 Days of Disimpaction and at Follow- to enable treatment, was reported
up Evaluation (2 Weeks After Disimpaction)
equally in the 2 groups.
Disimpaction Follow-up Evaluation
The dosage (PEG at 1.5 g/kg per day)
Enema PEG P Enema PEG P
(N 46) (N 44) (N 41) (N 39) and duration (6 days) of oral and rec-
Defecation frequency, mean 5.8 3.6 8.8 8.5 .64 7.7 5.3 8.7 6.4 .48 tal disimpaction were based on previ-
SD, times per wk ous studies that showed mean disim-
Fecal incontinence frequency, 3.4 4.3 13.6 12.6 .001 4.9 5.4 5.7 5.9 .58 paction times of 3 to 7 days.3,10,15,16 With
mean SD, times per wk
Abdominal pain, n 21 17 .33 23 17 .24 this regimen, successful disimpaction
Watery stools, n 10 28 .001 4 13 .03 was achieved with enemas and PEG for
80% and 68%, respectively, of the chil-
dren in our study. These results are in
ers. Before disimpaction, delayed CTT (n 31) than in the PEG group (n 16; accordance with other studies in
was found for 42 patients (95%) in the P .008). Abdominal pain that oc- which success with high doses of
enema group and 37 patients (97%) in curred immediately after enema use orally administered PEG was reached
the PEG group; delayed rectosigmoid resolved within 30 minutes for 23 in 92% to 97% of cases.3,10,15 In a retro-
segment CTT was found for 33 patients (77%) of 30 patients. spective chart review of clinical out-
(75%) and 33 patients (87%), respec-
comes in 5 hospitals in England and
tively (Table 3). As shown in Table 3, a DISCUSSION Wales, it was found that enemas were
significant decrease in CTT was found
This is the first prospective, random- successful for 73% of children with fe-
between intake and disimpaction in all
ized, controlled study demonstrating cal impaction, compared with 97% for
colonic segments (P .001). No signif-
that enemas and high-dose PEG (1.5 PEG.15 It is not possible to compare our
icant differences in CTT between the 2
g/kg) are equally effective in treating results with the latter study, however,
groups were found at any time point.
RFI in children with constipation. Chil- because a definition of fecal impaction
Behavior Scores dren who received enemas reported was lacking. Furthermore, it is not
A total of 38 patients (93%) in the en- fewer episodes of fecal incontinence clear how the investigators confirmed
ema group and 31 patients (79%) in and watery stools but more abdominal disimpaction in their study. The
the PEG group completed the question- pain directly after enema administra- strength of this study was that only
naires (Table 4). Struggles to adminis- tion. Defecation frequency increased children were included and reevalua-
ter medication, actions necessary to in both groups, and the occurrence of tion after therapy was performed
enable treatment, and levels of anxiety abdominal pain during the day, as re- through either rectal examination or
were reported equally in the 2 groups. ported in the bowel diaries, was not abdominal radiography.
Abdominal pain directly after adminis- different between the groups. Surpris- As expected, a high dosage of PEG re-
tration of the laxative was reported ingly, extra effort to administer medi- sulted in an increase in fecal inconti-
more frequently in the enema group cation, as well as tricks necessary nence frequency during the disimpac-
TABLE 3 Total and Segmental CTT Values
CTT P
Enema PEG
Intake (N 44) Disimpaction (N 41) Intake (N 38) Disimpaction (N 39) Intake Disimpaction
Ascending colon
Median (IQR), h 14.4 (7.2–43.2) 7.2 (2.4–21.6) 21.6 (9.0–50.4) 12.0 (7.2–24.0) .24 .47
Delayed 18 h, % 46 33 59 44
Descending colon
Median (IQR), h 21.6 (9.6–50.4) 9.6 (2.4–19.2) 24.0 (12.0–39.0) 7.2 (4.2–21.6) .69 .48
Delayed 20 h, % 51 23 56 32
Rectosigmoid segment
Median (IQR), h 57.6 (38.4–79.2) 24.0 (8.4–42.0) 61.2 (43.2–79.8) 20.4 (11.4–24.6) .57 .07
Delayed 34 h, % 75 29 87 13
Total colon
Median (IQR), h 117.6 (86.4–136.4) 37.2 (24.6–67.8) 120.0 (98.4–141.6) 43.2 (27.6–67.2) .89 .78
Delayed 62 h, % 95 72 97 75
Segmental and total CTTs decreased significantly after disimpaction in both groups (P .001). IQR indicates interquartile range.
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7. ARTICLES
TABLE 4 Behavior Scores at End of Disimpaction Week crease in fecal incontinence episodes
Enema (N 38) PEG (N 31) P after the intensive disimpaction period
Struggle to administer oral or rectal treatment in the current study.
Yes 24 17 .18
No 14 14 This is the first study to compare
Actions necessary to enable treatment (eg, distraction) changes in behavior in children with
Yes 21 18 .25 constipation, by using a questionnaire,
No 17 13
More anxious during disimpaction between treatment with enemas and
Yes 36 25 .13 treatment with oral laxative therapy. In
No 2 6 accordance with the general opinion
Abdominal pain soon after treatment
Yes 31 16 .008
regarding enema use in children, we
No 7 15 found that 95% of children receiving
If abdominal pain, how long did pain last? enemas exhibited fearful behavior.
5 min 6 5
5–15 min 10 3
However, we also found fearful behav-
15–30 min 7 2 ior for 81% of children receiving oral
30–60 min 2 1 laxative treatment. Given the compara-
1h 5 2
ble behavior in the 2 groups, disimpac-
Not applicable or not recorded 8 18
Who administered enema to child? tion with enemas should not necessar-
Father 5 0 ily be withheld to prevent anxiety. We
Mother 22 0
did not find more fearful behavior in
Both 9 0
Someone else 2 0 the enema group, which might be ex-
Not applicable 0 31 plained by the administration of ene-
After how much time did defecation occur? mas by parents at home instead of by
5 min 5 0
5–15 min 25 0 nurses in an unfamiliar environment
15–30 min 6 0 (hospital), which is more common in
30–60 min 1 0 practice. In adults, retrograde colonic
Not applicable 1 31
irrigation, which is performed by the
patients themselves, improved both
quality of life and bowel habits.24
tion period. PEG is a soluble inert be experienced as cramping and thus
polymer that acts by hydrogen- abdominal pain. The majority of pa- Rectal examinations to confirm the di-
bonding water molecules to expand tients (77%) experienced abdominal agnosis of constipation are controver-
the volume in the large intestine, re- pain relief within 30 minutes, and sial. Many pediatricians advocate
sulting in softer and more-watery overall abdominal pain, as reported avoidance of rectal examinations and
stools.17–19 Until the fecaloma has been in the bowel diaries, did not differ invasive treatments, such as rectal en-
cleared, soft stool leaks along the fecal between the treatment groups. Prob- emas, to prevent uncomfortable, pain-
mass in the rectum. An increase in ep- ful, and/or embarrassing situations.
ably parents and children qualified
isodes of fecal incontinence also was However, the North American Society
the abdominal pain directly after en-
found in a randomized, controlled trial for Pediatric Gastroenterology, Hepa-
emas differently.
evaluating the efficacy of PEG 3350.20 In tology, and Nutrition guidelines for
contrast, rectal enemas (dioctylsulfos- Fecal incontinence is associated with constipation in infants and children
uccinate) are hypertonic and stimu- lower quality of life with respect to recommend 1 digital examination of
late direct contraction of the colon. Di- both physical and psychosocial func- the anorectum, to evaluate the amount
rect contraction stimulates the rectum tioning, as reported by parents and by and consistency of stool and its loca-
to empty the fecal mass, which ex- children with constipation.21–23 There- tion within the rectum and to identify
plains why episodes of fecal inconti- fore, it is important to inform children organic disorders.6 In our center, rec-
nence were less common with ene- and parents that disimpaction with tal examinations are performed rou-
mas. As expected, however, abdominal oral PEG treatment is likely to cause tinely for children presenting with con-
pain directly after treatment was re- more episodes of fecal incontinence, stipation. If fecal impaction is present,
ported more frequently in the enema compared with disimpaction with ene- then rectal disimpaction is performed
group, because of the contractile ef- mas. In accordance with an earlier with enemas. This treatment regimen
fect. The increase in peristalsis might study,7 we observed a significant de- is based on a small study that sug-
PEDIATRICS Volume 124, Number 6, December 2009 e1113
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8. gested that rectal disimpaction shortly large, palpable, rectal mass were in- rectum in all of these children and the
after the onset of symptoms was more cluded. Such children have signifi- presence of a palpable abdominal fe-
effective than less-aggressive means cantly longer CTTs than children with cal mass in 37% to 66% of them.
of therapy.7 Because this study shows symptoms of constipation without This study has limitations. Because we
that enemas are not superior to oral RFI.26 The latter phenomenon, outlet included children with a history of en-
laxative treatment, we question the obstruction (ie, delay of transit at the ema use, as well as those without such
need for a rectal examination as a pre- level of the rectum), is found in both a history, the findings regarding fear-
requisite for the choice of oral or rec- children and adults with constipa- ful behavior might be confounded.
tal treatment. We suggest performing tion.4,27 Indeed, in our study, we found However, it is unclear whether chil-
rectal examinations only for children delays in rectosigmoid segment CTT dren with a history of enema use
for whom the diagnosis of constipation for 75% to 87% of patients. We also would be more or less anxious regard-
is uncertain, when they exhibit only 1 demonstrated that both CTT and ing enemas. The latter could not be ex-
symptom of the Rome III criteria for rectosigmoid segment CTT improved tracted from the behavior question-
constipation. Furthermore, a rectal ex- while defecation frequency increased naires we used in our study. A second
amination should be performed when during both oral and rectal disimpac- limitation is the assessment of behav-
symptoms of constipation persist after tion. This is in accord with the sugges- ior scores only after the start of disim-
initial oral or rectal disimpaction. Al- tion that a distended rectum, with fe- paction. However, the questions were
though anatomic problems are rare, a ces, slows down the motor activity of formulated in a way to detect changes
rectal examination may be necessary the colon, through an inhibitory recto- in behavior, rather than general be-
for such children. colonic feedback mechanism.28 It was havior at a single point in time.
In this study, CTT measurements were remarkable, however, that 72% to 75%
used as a noninvasive tool to localize of patients still had delayed CTT after CONCLUSIONS
delay of colonic transit and to verify disimpaction. This proportion is larger We demonstrated that enemas and
the effect of disimpaction. In contrast than that in earlier studies with a com- orally administered laxatives were
to previous observations for children parable group of children with consti- equally effective in treating RFI in func-
with constipation,25 both total and pation with RFI (ie, 30%–36%).25,29 It is tional childhood constipation. There-
rectosigmoid segment CTTs were likely that, in our current study, we in- fore, rectal enema treatment and oral
more delayed in our study. In our cluded children with more-severe mo- laxative treatment should be consid-
study, however, only children with a tility disorders, given the impacted ered equally as first-line therapy.
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10. Rectal Fecal Impaction Treatment in Childhood Constipation: Enemas Versus
High Doses Oral PEG
Noor-L-Houda Bekkali, Maartje-Maria van den Berg, Marcel G.W. Dijkgraaf, Michiel
P. van Wijk, Marloes E.J. Bongers, Olivia Liem and Marc A. Benninga
Pediatrics 2009;124;e1108-e1115
DOI: 10.1542/peds.2009-0022
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