Dataset Information

A trial to compare efficacy and tolerability of Plenvu and Picoprep as cleansing agents of the large bowel before colonoscopy (examination ofthe bowel with a fiberoptic device)

ABSTRACT: Primary objectives: Aim of the study is to compare the efficacy and tolerability of the relatively new bowel preparation Plenvu with the well established bowel preparation Picoprep as cleansing agents before colonoscopy. This is to test whether the low volume Polyethylin Glycol-electrolytes lavage solution preparation Plenvu would have non-inferior efficacy on bowel preparation compared with Picosulfate based Picoprep with a better effect on compliance and tolerability. Primary endpoints: The primary endpoint is the efficacy of cleansing preparations measured by the quality of cleansing. This is done using the validated Harfield Cleansing Scale. The cleansing quality is measured after dividing the colon into 5 segments (Rectum, sigmoid colon, Descending colon, Transverse colon, and Ascending colon/Cecum) and each segment is scored from 0 (irremovable heavy hard stool) to 4 (empty and clean), then a total grade is given. Grade A (all segments scored 3 or 4) and B (one or more segments scored 2) are considered as successful cleansing. Grade C (one or more segments scored 1) and D (one or more segments scored 0) is considered unsuccessful cleansing8.

DISEASE(S): The Trial Is About Comparing The Efficacy Of Plenvu With Picoprep. Bothare Bowel Cleansing Agents Prior To Colonoscopy. The Patients To Be Examined Are All Referred To Exclude Colorectal Cancer Disease.the Cleansing Process Is Not Directly Related To Treatment Of These Patients But Have An Effect On The Visualisation Of The Mucosa Of The Bowel And Thus The Quality Of The Colonoscopy.,The Trial Is About Comparing The Efficacy Of Plenvu With Picoprep. Bothare Bowel Cleansing Agents Prior To Colonoscopy. The Patients To Be Examined Are All Referred To Exclude Colorectal Cancer Di...,Endoscopy Large Bowel,Bowel Preparation

PROVIDER: 2736088 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

Project description: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

Dataset Information

A trial to compare efficacy and tolerability of Plenvu and Picoprep as cleansing agents of the large bowel before colonoscopy (examination ofthe bowel with a fiberoptic device)

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets