PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Background:

Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is needed.

Aim:

The efficacy and tolerability of three different bowel cleansing protocols used in children for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative (bisacodyl) compared with sennosides.

Methods:

Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day or PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days prior to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score, proportions of participants with excellent/good and with poor/inadequate bowel preparation), and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy evaluated with the visual analog scale. Analysis will be done on an intention to treat basis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Warsaw
• Collaborator: Institute of Child Health
• Treatments: Bisacodyl; Senna Extract; Sennoside A&B; Sennosides

Criteria

Inclusion Criteria:

• children 10 - 18 years of age referred for colonoscopy

• informed consent signed

Exclusion Criteria:

• allergy to PEG, sennosides or bisacodyl

• disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.)