drugset / Trial / NCT01531140

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

NCT01531140

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2010-11
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bisacodyl Small molecule 10 mg Oral
Subject Bisacodyl Small molecule 15 mg Oral
Subject Sennosides Unknown 8.6 mg
Comparator polyethylene glycol Other / unclassified 30 unknown Oral
Comparator polyethylene glycol Other / unclassified 60 unknown Oral

Indications

No indication recorded.