drugset / Trial / NCT03011788

Polyethylene Glycol Cleansing in Patients at High Risk for Poor Bowel Preparation

NCT03011788

Unknown 270 enrolled VA Connecticut Healthcare System
RandomizedParallel-groupSingle-blindScreening

Summary

The aim of this randomized trial is to compare the proportion of patients achieving an adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2 consecutive days in a population identified as high risk for an inadequate bowel preparation. 2\. Research Design: This study is a single-center prospective randomized study at the West Haven VAMC. 3\. Methodology: 1. Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left, transverse, and right). 2. Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated polyp/adenoma detection rate, patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to bowel preparation Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high risk for poor bowel preparation,

Timeline

Start
2017-01
Primary completion
2020-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator polyethylene glycol Other / unclassified 4 ml Oral
Comparator polyethylene glycol Other / unclassified 8 ml Oral

Indications

No indication recorded.