Recruiting

Golytely vs. 2-Day Regimen

Sponsor:

VA Connecticut Healthcare System

Code:

NCT03011788

Conditions

Colonoscopy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Golytely Oral Solution

Study Details

Brief 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

Study ID

NCT03011788

Start date

Jan, 2017

Status verified date

Dec, 2019

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Risk factors that increase likelihood of poor bowel prep

Exclusion Criteria:

  • prior colon resection
  • Women of child bearing age

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Single day

Single day Golytely purge 4L purge

active comparator: 2 day colon purge

Two days of Golytely purge 8L purge

Interventions

Golytely Oral Solution

Bowel purge prior to,colonoscopy

Primary outcome measure

  • Boston Bowel Preparation Scale (BBPS) [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

West Have VAMC

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

More Information

Sponsor

VA Connecticut Healthcare System

Last update posted

Dec 3, 2019

Last verified

Dec, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Connecticut Healthcare System on 2019-12-03.