Actively Recruiting
Early Ileostomy Closure for Rectal Cancer Patients in North America
Led by Jewish General Hospital · Updated on 2022-08-23
118
Participants Needed
4
Research Sites
236 weeks
Total Duration
On this page
Sponsors
J
Jewish General Hospital
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Our preliminary work demonstrates that there is buy-in from both patients and surgeons with regards to early ileostomy closure (EIC) for select rectal cancer patients undergoing restorative proctectomy (RP) and diverting loop ileostomy (DLI). The feedback from leaders in Europe further supports the need for a large scale randomized-controlled trial (RCT) on this subject in North America. Should the results of such a study be favourable, we believe it could support a change in practice that would be beneficial to patients and the health care system alike. Furthermore, our work will help identify which patients and practices are suitable for EIC. The goal of our project is to determine whether EIC in rectal cancer patients undergoing RP with a DLI is safe, feasible and beneficial in a North American population. Specifically, our primary objective is to compare the severity of complications between patients undergoing EIC versus traditional (late) closure. Our secondary objectives include assessing the difference in quality of life (QoL), early and late bowel function, and cost of care between these two groups.
CONDITIONS
Official Title
Early Ileostomy Closure for Rectal Cancer Patients in North America
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (18 years or older) female patients
- Underwent restorative proctectomy with diverting loop ileostomy for rectal cancer by laparoscopic, robotic, transanal, or open approach
- Negative anastomotic leak test with CT scan and rectally-administered water-soluble contrast on post-operative day 7, 8, or 9
You will not qualify if you...
- Peri-operative immunosuppression within 6 weeks of surgery
- Age-adjusted Charlson Comorbidity Index greater than 6
- Other major surgery during the initial operation
- Any major complications (Clavien Dindo Grade III or higher) after restorative proctectomy
- Inability to speak or understand English or French and inability to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, Canada
Actively Recruiting
2
London Health Sciences Centre
London, Ontario, Canada
Actively Recruiting
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Actively Recruiting
4
McGill University Health Centre
Montreal, Quebec, Canada
Actively Recruiting
Research Team
N
Natasha Caminsky, MD
CONTACT
S
Sarah Sabboobeh, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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