Phase 4
N=2,239
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03298945 ↗Enrolled (actual)
2,239
Serious AEs
0.5%
Results posted
Jan 2025
Primary outcome: Primary: Colonoscopy Completion Rate — 591; 600 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Miralax-Gatorade Prep (Drug); Golytely (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Colonoscopy Completion Rate |
591; 600 | — |
| PRIMARY Population Level Adenoma Detection Rate (ADR) |
383; 364 | — |
| SECONDARY Cancellation or No-show in Each Bowel Prep Arm |
358; 330 | — |
| SECONDARY Adequate Bowel Prep Quality |
— | — |
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 scheduled colonoscopies which in turn undermines the effectiveness of colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel preparation in the VA is of larger volume and less palatable than another commonly used bowel preparation regimen. The investigators propose to compare these two commonly used bowel preparations with respect to the overall completion rate of scheduled colonoscopies in a real-world VA practice setting. The results of the study can be immediately applied to maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.
Eligibility Criteria
Inclusion Criteria
- > 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03298945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.