Introduction
Colonoscopy in children has become a crucial diagnostic tool for various colonic diseases
such as rectal bleeding, chronic diarrhea, inflammatory bowel disease, and more. Satisfactory
colon preparation is considered a major limiting factor in achieving adequate colon
conditions to assess mucosal appearance, histology, and/or to perform different surgical
procedures. Colon cleansing protocols adopted from adult practices were not appropriate
for children for various reasons, including undesirable flavor and the large volume
needed [1]. In recent years, different pediatric PEG-3350-based colon cleansing protocols were
reported in the literature, which differed in length of preparation (1 to 4 days)
and laxative dose (1 – 4 g/Kg/d) [2]
[3]
[4]
[5]
[6]. In accordance with research guidelines, in all cited prospective studies, protocols
were performed under strict research conditions. To our knowledge, the corresponding
authors of those protocols have not provided evidence to confirm that their published
protocols are successful under normal clinical conditions. Accordingly, the applicability
of those protocols for general gastroenterologists is unproven. We believe that a
successful research protocol should be used routinely by the authors in their normal
clinical practices to show the suitability of their research protocol for clinical
practice. This supposition is supported by overall failure rates for different cleansing
protocols in children, which were estimated in different studies between 21 % and
34 % [7]
[8]
[9]
[10]
[11]. Whether the high rate of unprepared colons reflects the failure of a previously
published research protocol or new protocol used by the respected authors is not known.
It is obvious that assessing research protocols in routine clinical practices may
reduce the rate of failed colon preparation in the practices of general gastroenterologists.
In 2013, we published a prospective research study that compared the success rate
of colon preparations between 2- and 4-day colon cleansing protocols in children.
In that study, other colonoscopy landmarks were measured including: terminal ileum
(TI) intubation rate and clinical side effects (vomiting, abdominal pain). Our results
showed an adequate preparation rate of 73.6 % after the 2-day protocol [11].
Since that publication, we have incorporated this protocol into our routine clinical
practice and collected data from a suitable number of procedures to be able to report
our results. Accordingly, in the current study, we compared the colon preparation
rate between the strict research protocol and the same protocol performed under routine
clinical practice.
Patients and methods
In this retrospective study, the colon cleansing protocol included PEG-3350 at a dose
of 2 g/kg/day plus Dulcolax (Bisacodyl, Boehringer Ingelheim, Texas, United States)
5 mg/day as previously described [11]. Patients were instructed to mix 8 oz of liquid for each 17 g of PEG 3350 consumed,
provided that the liquid was not red. Patients also completed a questionnaire that
included the amount of PEG-3350 consumed per day, the number of stools per day, the
consistency of each stool (graded previously as: G1 – hard stool, G2 – firm stool,
G3 – curd form stool, G4 – soft stool, G5 – loose/liquid stool, G6 – watery/thin stool
[3], and side effects (vomiting, abdominal pain). All patients who underwent colonoscopies
for different medical reasons were included in the study. No exclusion criteria were
used. Adequate colon preparation was defined according to Vanner SJ [12] and Barclay et al. [13] with modifications (G1 – unacceptable, G2 – poor, G3 – fair, G4 – good, G5 – excellent).
Colon preparation of grade ≥ 4 was considered adequate preparation in both studies
(research and routine clinical practice). Implementation of the research protocol
differed from that in routine clinical setting in the following ways: 1. Patients
were instructed to call in for any protocol deviations; 2. Review of patients’ questionnaires
was performed before the procedures; 3. Colon preparation grading was also assessed
independently by the endoscopic nurse; and 4. Final preparation grading was calculated
as the average of grading of both reviewers: the gastroenterologist (YE) and the endoscopy
nurse. The study was approved by the Marshall University School of Medicine Institutional
Review Board.
Results
A total of 89 colon cleansing protocols were performed in children aged 3 to 22 years.
The most common indications for colonoscopy were gastrointestinal bleeding or inflammatory
bowel disease in patients undergoing colonoscopy as part of their clinical investigation
or follow-up. The patients’ average age was 13.9 years and the male to female ratio
was 1.53:1.0 ([Table 1]). As expected, abdominal cramps related to the PEG 3350 were noted in 41 patients
(46 %), which did not result in any protocol violations. Vomiting was noted in 3 (3.3 %)
patients. Similar results were noted in the previous study, showing abdominal cramps
in 32 % and vomiting 2.5 % [11]. No patients failed to complete the colon cleansing protocol due to side effects.
Overall, the adequate colon preparation rate (≥ 4.0) was 75 % and successful terminal
ileum (TI) intubation was noted in 89 % of the procedures. Incomplete TI intubation
was noted in 10 procedures of which inadequate colon cleansing was noted in 3 patients,
no TI in 1 patient (post-surgery), anatomical stenosis in 5 patients, and failed intubation
in 1 patient. Under research conditions, incomplete TI intubation was noted in 2 children,
both due to anatomical stenosis. The odds of achieving adequate colon cleansing were
similar regardless of whether it was performed under research conditions or clinical
practice (OR 1.1; CI 95 % 0.4 – 2.5; P = 0.8275). Chi-square and Fisher’s Exact Test were used to compare Colon Cleansing
Grading (≥ 4) and TI Intubation rate. One-way ANOVA and Mann-Whitney was used to compare
the number of stools/day, stool consistency, and the average of the colon cleansing
grading. The odds ratio, confidence interval, and P values in the results were calculated using Chi-square and Fisher’s Exact test using
the Baptista-Pike method. All statistics were calculated using Graph Pad Prism, version
7.03, by GraphPad Software, Inc., LaJolla, Ca, USA.
Table 1
Colon cleansing results.
|
Clinical practice
|
Research protocol [11]
|
P value
|
|
Number of patients
|
89
|
38
|
|
|
Age (years) (mean + SD)
|
13.9 ± 4.2
|
9.9 ± 4.7
|
|
|
M/F ratio
|
1.5: 1.0
|
0.8:1.0
|
|
|
Number of stools/day (mean + SD)
|
7.9 ± 4.1
|
7.5 ± 4.2
|
0.6648
|
|
Stool consistency grade (mean + SD)
|
5.6 ± 0.66
|
5.6 ± 0.63
|
0.920
|
|
Colon cleansing grade (mean + SD)
|
4.0 ± 0.94
|
4.1 ± 0.79
|
0.6292
|
|
Colon cleansing grade > 4.0
|
67 (75.3 %)
|
28 (73.7 %)
|
0.8275
|
|
TI intubation
|
72 (88.9 %)
|
36 (94.7 %)
|
0.4992
|
M, male; F, female; SD, standard deviation; TI, terminal ileum
Discussion
Colon preparation is the crucial limiting factor for successful evaluation of the
colon, as well as for diagnostic purposes or surgical procedures. In a review of over
12,800 colonoscopies in adults, colon cleansing quality was a decisive factor in detection
of polyps [14]. Others reported that repeated colonoscopies on previously inadequate colon preparations
were successful in only 90 % of cases, while 10 % were inadequately prepared the second
time [15]. Different reports in children showed that an inadequate preparation rate ranged
between 21 % and 34 % [7]
[8]
[9]
[10]. The wide range of unprepared colons in children is probably related to the different
cleansing protocols utilized in each study, and existed in spite of the close monitoring
of the patients during the respective, prospective research protocols. Incomplete
colonoscopies are also associated with a significant burden on the patients and their
families due to the psychological effects, anesthesia involved, and extra medical
expenses related to repeat procedures [16]. Another factor that has not been evaluated on this topic is the practicality of
the suggested cleansing protocols used in research studies, namely, none of the respective
authors have provided documentation that their protocols would be successful in real-life
practices. This is an important point, as the real value of any research protocol
is its practical use in the clinical practices of ordinary gastroenterologists, who
perform their cleansing protocols without the strict conditions of research protocols.
Without such proof, those cleansing protocols performed under research conditions
could be lost in the literature and may never reach “real world practice.”
We acknowledge that the limitation of our study was mainly that the number of patients
in the two groups were not comparable in size. The research protocol only had 38 patients
participate compared to the 89 patients from the clinical practice. Nonetheless, no
significant differences were noted between the groups.
Conclusion
In summary, we presented in this study data from our previously published prospective
2-day colon cleansing research protocol and compared the results to the same procedure
used under the conditions of our routine clinical practice. In this retrospective
study we showed that the colon preparation rate was similar to the result obtained
under the previous research conditions and confirmed that this protocol is applicable
for use in routine clinical practices. Other colonoscopy landmarks including intubation
of the TI and side effects were also similar in both protocols. To our knowledge,
this is the first comparison of the same colon cleansing protocol under research conditions
and routine clinical practice reported in children. We recommend that physicians who
suggest a new colon cleansing protocol provide follow-up data to show that their protocol
can be utilized in their own routine clinical practice; i. e.: without the restrictions
associated with research protocols. This information will demonstrate that their protocol
is applicable for physicians in other non-academic medical centers.
Without such proof, the published research protocols could be buried in the medical
literature and never be practiced in the real world.
