Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

Not Applicable

Completed

• Conditions: Children Prior to Colonoscopy
• Interventions: Device: polyethylene glycol 3350

• Registration Number: NCT02102373
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-29
• Study First Posted: 2014-04-02
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-22
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-fiber diet	polyethylene glycol 3350	Patients received low-fiber diet for 24 hours before colonoscopy
clear liquid diet	polyethylene glycol 3350	Patients received clear liquid diet for 24 hours before colonoscopy

Primary Outcome Measures

Name	Time	Method
Bowel preparation of the whole colon	in 15 minutes after colonoscopy	Boston bowel preparation score for the whole colon assessed by the endoscopist in 15 minutes after the procedure

Secondary Outcome Measures

Name	Time	Method
Bowel preparation for colon sections	in 15 minutes after colonoscopy	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
Duration of PEG taking	in 15 minutes after colonoscopy
Tolerability	in the first 6 hours after colonoscopy	Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort
Time between the last dose of PEG and colonoscopy	in 15 minutes after colonoscopy
Acceptability	in the first 6 hours after colonoscopy	Patient's satisfaction of bowel preparation measured by 10-point visual-analogue scale (VAS)

Trial Locations

Locations (1)

Department of Pediatric Gastroenterology and Nutrition; 🇵🇱 Warsaw, Poland