drugset / Trial / NCT03074448

Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-endoscopy Bowel Preparation

NCT03074448

Phase 3 Completed 314 enrolled Kaiser Clinic and Hospital
Non-randomizedParallel-groupSingle-blindTreatment

Summary

Poor or inadequate bowel preparation is one of the most common reasons for a repeated or failed colonoscopy. Preparation methods shown to be effective include the use of either bowel-cleansing devices or oral laxatives. Despite the acceptable effectiveness and safety of both bowel-cleansing methods, very few studies have been performed to evaluate which method is more effective. The main aim is to perform an observational study followed by propensity score modeling to evaluate and compare the quality of bowel preparation with the use of Aquanet bowel-cleansing devices versus the use of oral Sodium picosulfate solution. The study will involve 314 patients requiring a colonoscopy, between 14 and 90 years of age and with more than three bowel movements per week for the past one month. Outcomes of interest being the quality of bowel preparation evaluated through the Boston Bowel Preparation (BBP) scale. The investigator hypothesized that the bowel preparation with Aquanet bowel-cleansing device for colonoscopy will provide a better outcome for the patient than with conventional methods.

Timeline

Start
2014-05
Primary completion
2014-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Picosulfate Unknown Oral

Indications

No indication recorded.