Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Children Prior to Colonoscopy
• Intervention / Treatment: Device: polyethylene glycol 3350

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-184
    • Department of Pediatric Gastroenterology and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low-fiber diet; Patients received low-fiber diet for 24 hours before colonoscopy	Device: polyethylene glycol 3350; 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.; Other Names: Forlax
Active Comparator: clear liquid diet; Patients received clear liquid diet for 24 hours before colonoscopy	Device: polyethylene glycol 3350; 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.; Other Names: Forlax

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Publications and helpful links

General Publications

• Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.

Helpful Links

• Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: March 29, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 22, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: colonoscopy, pediatric, preparation, diet
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: Mytyk2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO