Optimal Bowel Cleansing Trial

Bowel Cleansing for Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624454
• Other study ID #: SUS-CRAP
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: May 7, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bowel Cleansing for Colonoscopy

Intervention

Other:
• Laxabon
4 l PEG solution split dose cleansing
• CitraFleet
Small volume osmotic bowelcleansing

Locations

Country	Name	City	State
Norway	Sørlandet sykehus	Kristiansand	VestAgder
Norway	OUS Rikshospitalet, dept of med gastro	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel cleansing quality		1 Day	No
Secondary	Colonoscopy findings		1 Day	No