NCT01624454

Optimal Bowel Cleansing Trial

Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter

Detailed description

This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase. The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.

Conditions

• Bowel Cleansing for Colonoscopy

Interventions

Type	Name	Description
OTHER	Laxabon	4 l PEG solution split dose cleansing
OTHER	CitraFleet	Small volume osmotic bowelcleansing

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-06-20
• Last updated: 2013-05-09

Locations

2 sites across 1 country: Norway