Optimal Bowel Cleansing Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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

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Bowel Cleansing for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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large volume

bowel cleansing with PEG

Group Type ACTIVE_COMPARATOR

Laxabon

Intervention Type OTHER

4 l PEG solution split dose cleansing

Osmotic

Group Type ACTIVE_COMPARATOR

CitraFleet

Intervention Type OTHER

Small volume osmotic bowelcleansing

Interventions

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Laxabon

4 l PEG solution split dose cleansing

Intervention Type OTHER

CitraFleet

Small volume osmotic bowelcleansing

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No