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PLENVU vs Prepkit-C Bowel Preparation for Colonoscopy

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NIAID Data Ecosystem2026-03-10 收录
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/2466942
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Interventions: PLENVU is a novel, low volume (1L) polyethylene glycol based bowel preparation that has demonstrated a good safety profile and an overall bowel cleansing success in two European and one American phase 3 trials,. Consenting patients who are to undergo routine colonoscopy will be randomised to receive PLENVU or the standard bowel preparation at Alfred Hospital using Prepkit-C. Participants will be provided instruction sheets for taking the preparation to which they are allocated. To assess acceptance and tolerance, participants will be asked to complete a questionnaire on the day of and ahead of the procedure. Primary outcome(s): Bowel cleanliness will be assessed using the Boston Bowel Preparation Scale as follows: Each of the 3 segments of the colon (right, including the cecum and ascending colon; transverse, including the hepatic and splenic flexures; and left, including the descending colon, sigmoid, and rectum) will be given a score from 0 to 3 defined as: 0 - unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared 1 - portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid 2 - minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well 3 - entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid Each of the 3 segment scores is then summed for a total score of 0 to 9, in which 0 is unprepared and 9 is entirely clean. If an endoscopist aborts a procedure because of inadequate preparation, then any non-visualized proximal segments are assigned a score of 0. Successful bowel preparation requires a minimum BBPS of 6 with a score of 2 or more in each bowel segment. [Day of colonoscopy procedure] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy
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2018-07-15
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