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

NCT03011788 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2019-12-03

No results posted yet for this study

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,

Conditions

  • Colonoscopy

Interventions

DRUG

Golytely Oral Solution

Bowel purge prior to,colonoscopy

Sponsors & Collaborators

  • VA Connecticut Healthcare System

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011788 on ClinicalTrials.gov