Bowel Cleansing for Colonoscopy Clinical Trial
Official title:
Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial
Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic