Status:
COMPLETED
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Lead Sponsor:
VA Office of Research and Development
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
From the patients' perspective, the most formidable part of the colonoscopy experience is the process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to incompletion of sc...
Detailed Description
Anticipated Impacts on Veterans Health Care: by identifying a colonoscopy bowel preparation regimen which is the most effective in real-world VA practice and can be immediately implemented on a VA-wid...
Eligibility Criteria
Inclusion
- \> 18 years of age, and
- being scheduled for outpatient elective screening, surveillance or diagnostic colonoscopies, and
- the provider ordering the colonoscopy giving permission to enroll the patient.
Exclusion
- Patients who are \<18 years
- undergoing inpatient colonoscopy
- those with contra-indications to receiving the standard 4L PEG-ELS colonoscopy bowel preparation (e.g., allergy to PEG) will be excluded
- Those with a preference for a specific bowel preparation will be excluded.
- The investigators are excluding inpatient colonoscopies because they account for a very small fraction of the total colonoscopies performed.
- Also, inpatient colonoscopies are often performed for urgent reasons such that rapid bowel preparation procedures are followed.
- In addition, because the objective of inpatient colonoscopy is often not to look for small polyps, the threshold for "adequate" bowel preparation quality might be different from that for outpatient procedures.
- In addition, for patients undergoing more than 1 colonoscopy during the study period, only their first colonoscopy will be included in the primary analysis.
- Patients who are undergoing a repeat colonoscopy for to a recent inadequate colonoscopy examination with poor bowel preparation will be excluded.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
2239 Patients enrolled
Trial Details
Trial ID
NCT03298945
Start Date
December 13 2018
End Date
June 30 2024
Last Update
February 5 2025
Active Locations (1)
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1
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104-4551