Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

Study Overview
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Brief Summary
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Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing of bowel preparation is the key factor and recommends that the delay between the last dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to colonoscopy has not been studied in children population, yet. The diet regimen before colonoscopy is likely less important than the timing of bowel preparation, however may influence the well-being of children.

Official Title
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Clear Liquid vs Low-fiber Diet in Bowel Cleansing for Colonoscopy in Children: a Randomized Trial

Conditions
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Children Prior to Colonoscopy

Intervention / Treatment
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* Device: polyethylene glycol 3350


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6-18 years Elective colonoscopy Exclusion Criteria: Chronic renal, liver, or heart failure Acute surgical abdominal conditions (e.g., acute obstruction or perforation) Acute surgical abdominal conditions (e.g., acute obstruction or perforation) Any prior gastrointestinal surgery

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low-fiber diet<br>Patients received low-fiber diet for 24 hours before colonoscopy | Device: polyethylene glycol 3350<br>* Patients received a polyethylene glycol 3350 solution starting at afternoon the day before the colonoscopy at a dose of 1000 ml/15 kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.<br>* Other names: Forlax;|
| Active Comparator: clear liquid diet<br>Patients received clear liquid diet for 24 hours before colonoscopy | Device: polyethylene glycol 3350<br>* Patients received a polyethylene glycol 3350 solution starting at afternoon the day before the colonoscopy at a dose of 1000 ml/15 kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.<br>* Other names: Forlax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation of the whole colon | Boston bowel preparation score for the whole colon assessed by the endoscopist in 15 minutes after the procedure | in 15 minutes after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation for colon sections | Boston bowel preparation score for: the right side of the colon the transverse section of the colon the left side of the colon assessed by the endoscopist in 15 minutes after the colonoscopy | in 15 minutes after colonoscopy | 
| Duration of PEG taking |  | in 15 minutes after colonoscopy | 
| Time between the last dose of PEG and colonoscopy |  | in 15 minutes after colonoscopy | 
| Acceptability | Patient's satisfaction of bowel preparation measured by 10-point visual-analogue scale (VAS) | in the first 6 hours after colonoscopy | 
| Tolerability | Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort | in the first 6 hours after colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, pediatric, preparation, diet