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OpenTrials
Completed

NCT Number: NCT01624454

Optimal Bowel Cleansing Trial

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

Completed

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Key information

Conditions

Bowel Cleansing for Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OUS Rikshospitalet, dept of med gastro, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laxabon

Other

4 l PEG solution split dose cleansing

CitraFleet

Other

Small volume osmotic bowelcleansing

Primary outcomes

  1. Bowel cleansing quality

    Time frame: 1 Day

Secondary outcomes

  1. Colonoscopy findings

    Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
May 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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