Colonoscopy Preparation Clinical Trial
Official title:
Randomized Clinical Trial to Evaluate the Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid in Patients With Past Poor Colonic Preparation
The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume polyethylene glycol preparation in subjects with past history of poor bowel preparation
Two key quality indicators for colonoscopy are the cecal intubation rate and the percentage
of neoplastic lesions detected. Both factors are associated with adequate bowel cleansing.
Poor cleansing ranged from 5% to 30% across studies, negatively affecting the efficiency of
colonoscopy.
The most important factor associated with poor colonic preparation is the past history of
poor bowel preparation. However, there are no recommendations on the proper type of
preparation in those patients. In two non-randomized studies inadequate cleansing in the
second colonoscopy ranged from 9.8% to 23%. Randomized studies comparing high volume (3-4
liters) with low volume (2 liters) PEG preparations, which are better tolerated by patients,
are therefore needed before making any recommendations in this regard.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
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