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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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,

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Connecticut Healthcare System

Criteria

Inclusion Criteria:

• Risk factors that increase likelihood of poor bowel prep

Exclusion Criteria:

• prior colon resection

• Women of child bearing age