Status:
COMPLETED
Optimizing Timing of Follow-up Colonoscopy
Lead Sponsor:
University of Manitoba
Conditions:
Colo-rectal Cancer
Colon Polyp
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillan...
Detailed Description
Study design and intervention: This will be a cluster randomized controlled trial in which individual endoscopy physicians (gastroenterologists and surgeons) will be randomized (stratified by physicia...
Eligibility Criteria
Inclusion
- For physician participants, there are no age limits/parameters. All physicians performing colonoscopy on adult patients in Winnipeg will be eligible to participate (other than those involved in pilot testing and study investigators). Participating physicians will be informed that the introduced intervention will be an information tool to help improve care for individuals undergoing colonoscopy, and will be asked to consent to review of their patient records. Participating physicians will be informed that no individual-level information will be disclosed at any time and all analysis will be on anonymized data.
- For patient participants:
- Patients must be older than 50 years and up to 75 years old for inclusion in the study data.
- Adequate bowel preparation defined by Boston Bowel Preparation Scale Score of ≥ 2 in each of segments of the colon (Boston bowel prep scale score recording is mandatory in the Winnipeg city-wide endoscopy reporting system);
- Colonoscopy completed to the cecum/ileocolonic anastomosis;
- Colonoscopy performed between 1 to 4 months before randomization of endoscopy physician (to determine baseline adherence) or between 3 to 7 months after randomization (to determine effect of the intervention).
Exclusion
- Physicians will be excluded if they are away for more than six weeks continuously in the six months after randomization. In this situation, an alternate physician will be recruited and randomized. Thus there is no anticipated loss of follow-up.
- Patients will be excluded if any of the following criteria are met:
- History of inherited CRC predisposition (Lynch Syndrome, Familial adenomatous polyposis, others);
- Inflammatory bowel disease;
- Partially excised polyp or endoscopy physician recommending early colonoscopy to document complete excision;
- Endoscopy physician documenting a rationale for not repeating colonoscopy in future such as co-morbid conditions.
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04889352
Start Date
July 15 2021
End Date
December 31 2022
Last Update
April 6 2025
Active Locations (2)
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1
Health Sciences Center
Winnipeg, Manitoba, Canada, R3E 3P4
2
Winnipeg Regional Health Authority
Winnipeg, Manitoba, Canada, R3E 3P4