NCT03298945CompletedPhase 4
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
Source: ClinicalTrials.gov · Last updated 5 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2239 (actual)
- First submitted
- 26 Sept 2017
- Start date
- 13 Dec 2018
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Colorectal cancer
- NCT number
- NCT03298945
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 2239
- From 13 Dec 2018 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- those with contra-indications to receiving the standard 4L PEG-ELS colonoscopy bowel preparation (e.g., allergy to PEG) will be excluded
Age
- Patients who are \<18 years
Other
- undergoing inpatient colonoscopy
- 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.
Who the study is looking for
- \> 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.