Optimal Bowel Cleansing Trial

Not Applicable

Completed

• Conditions: Bowel Cleansing for Colonoscopy
• Interventions: Other: Laxabon; Other: CitraFleet

• Registration Number: NCT01624454
• Lead Sponsor: Helse Stavanger HF

Brief 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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-06
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Pts for out-patient colonoscopy
• age 18-80

Exclusion Criteria

• Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
• Suspicion of renal insufficiency or ileus/subileus
• Previous colonic surgery
• Pregnancy
• Inability to adhere to cleansing instructions
• Inability to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
large volume	Laxabon	bowel cleansing with PEG
Osmotic	CitraFleet	-

Primary Outcome Measures

Name	Time	Method
Bowel cleansing quality	1 Day

Secondary Outcome Measures

Name	Time	Method
Colonoscopy findings	1 Day

Trial Locations

Locations (2)

Sørlandet sykehus; 🇳🇴 Kristiansand, VestAgder, Norway

OUS Rikshospitalet, dept of med gastro; 🇳🇴 Oslo, Norway