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
1 other identifier
interventional
270
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 3, 2019
December 1, 2019
3.9 years
January 3, 2017
December 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Adenoma detection rate
Day 1
patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire
Day 1
Study Arms (2)
Single day
ACTIVE COMPARATORSingle day Golytely purge 4L purge
2 day colon purge
ACTIVE COMPARATORTwo days of Golytely purge 8L purge
Interventions
Bowel purge prior to,colonoscopy
Eligibility Criteria
You may qualify if:
- Risk factors that increase likelihood of poor bowel prep
You may not qualify if:
- prior colon resection
- Women of child bearing age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Have VAMC
West Haven, Connecticut, 06516, United States
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Of Endoscopy, Associate professor Internal Medicine
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 5, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
December 3, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share