Status:
COMPLETED
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial
Lead Sponsor:
Jewish General Hospital
Collaborating Sponsors:
Providence Healthcare
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Rectal Cancer
Surgery
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
After undergoing restorative proctectomy for rectal cancer, many patients are left with significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased LARS severity correlat...
Eligibility Criteria
Inclusion
- Adult patients (\>=18 years-old) who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure
Exclusion
- Patients from whom clear and informed consent cannot be obtained
- Patients unable to read and comprehend English or French
- Patients who cannot be contacted by telephone
- Patients who have undergone major colonic resection in addition to their proctectomy
- Patients on active chemotherapy or radiotherapy treatment
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03828318
Start Date
September 1 2019
End Date
January 31 2024
Last Update
November 29 2024
Active Locations (6)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Providence Healthcare
Vancouver, British Columbia, Canada
3
University of Manitoba
Winnipeg, Manitoba, Canada
4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2