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

A Randomized Study of Single vs Two-Day Polyethylene Glycol Cleansing in Patients at High Risk for Poor Bowel Preparation

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,

Study Overview

• Status: Unknown
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Golytely Oral Solution

Detailed Description

Group 1: One day of split-dose Golytely 4L (2 liters the evening before procedure, 2 liters the morning of procedure) Group 2: Two days of split-dose Golytely 4L (beginning 2 days before the procedure with 2 liters in the evening, 2 liters the morning of the day before the procedure, 2 liters the evening before the procedure, 2 liters the morning of the procedure) Patients will be instructed to ingest each of the 2-liter aliquots of Golytely over 2 hours.

Diet: Both groups will be instructed to ingest a low-residue diet beginning 2 days before the procedure, (attachment 2) the last low-residual meal at 4 pm on day prior to procedure, with no food on the day of the procedure. Clear liquid diet after 4 pm on day prior to procedure and clear liquids on the day of procedure up-to 4 hours prior to the procedure.

Education: Both groups will receive face to face, pre-procedure education 1 week prior to their procedure. Patient who cannot come for face-to-face education will not be included in the study.

Reminders: Both groups will receive a telephone call 2 days prior to their procedure to remind them of their procedure and to remind them to take the laxative preparation as prescribed.

Compliance: Patient will receive an educational handout about bowel preparation and colonoscopy. This practice is standard for all patients receiving colonoscopy at our institute. All Patients will get a copy of low residual diet and be asked to complete diet intake handout for 2 days prior to procedure. Patients will be requested to bring their unused Golytely prep medications to evaluate compliance.

Tolerability: The tolerability of the bowel preparation will be assessed using the validated Mayo clinic bowel prep tolerability questionnaire. (Attachment 3) On the day of the procedure, a member of the research team will review the patient's diet for the previous 2 days, the proportion of bowel prep solution ingested, and complications potentially related to the preparation (described above); the patient will also complete the Mayo tolerability questionnaire. Orthostatic vital signs will be checked prior to colonoscopy. Patient will undergo colonoscopy by an endoscopist following our standard protocols at WHVA MC. The bowel preparation will be scored using the BBPS and all polyps identified will be recorded and removed in the standard fashion.

Following discharge, patients will receive a telephone call within 2 days to document any post-procedure complications, including emergency room visits or hospitalizations.

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • Recruiting
      • West Have VAMC
      • Contact: anil nagar, MD; Phone Number: 2830 203-932-5711; Email: anil.nagar@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Risk factors that increase likelihood of poor bowel prep

Exclusion Criteria:

• prior colon resection
• Women of child bearing age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single day; Single day Golytely purge 4L purge	Drug: Golytely Oral Solution; Bowel purge prior to,colonoscopy; Other Names: Bowel purge
Active Comparator: 2 day colon purge; Two days of Golytely purge 8L purge	Drug: Golytely Oral Solution; Bowel purge prior to,colonoscopy; Other Names: Bowel purge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Bowel Preparation Scale (BBPS)	Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Adenoma detection rates	Day 1
patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire	patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire	Day 1

Collaborators and Investigators

• Sponsor: VA Connecticut Healthcare System

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: AN0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No