Actively Recruiting
Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)
Led by Jewish General Hospital ยท Updated on 2022-08-23
118
Participants Needed
4
Research Sites
52 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
This research aims to evaluate early ileostomy closure (EIC) in adults with rectal cancer who have undergone restorative proctectomy and creation of a diverting loop ileostomy (DLI). The study investigates whether EIC is safe, feasible, and beneficial compared to the traditional late closure method. It will focus on comparing complication severity and also assess quality of life, bowel function, and cost of care in a North American population. Participants who meet eligibility undergo a leak test with flexible sigmoidoscopy and CT scan between post-operative days 7 and 9. Those with a negative test are randomized into two groups: one group receives EIC with reversal of their DLI between days 10 and 14 post-surgery, using specific surgical techniques without epidural analgesia, and the other group undergoes standardized late closure no earlier than 12 weeks after surgery. During the study, researchers will monitor complications at multiple time points up to 12 months post-surgery, including comprehensive complication index scores and post-operative ileus occurrence. They will also evaluate recovery using PROMIS 29, bowel function with the LARS score, quality of life using EORTC questionnaires, and healthcare costs. Follow-up assessments occur regularly over the year, with data collected on hospital stays, interventions, and appliance costs to understand the overall impact of early versus traditional ileostomy closure.
CONDITIONS
Brief 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) patients
- Underwent restorative proctectomy with creation of a diverting loop ileostomy for rectal cancer
- Negative anastomotic leak test via CT scan with 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 index operation
- Any major complications (Clavien Dindo Grade III or greater) following restorative proctectomy
- Inability to speak or understand English or French and inability to give informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including CT scan with rectally-administered contrast and flexible sigmoidoscopy
Duration - Up to 12 weeks following restorative proctectomy
Participants undergo restorative proctectomy with creation of a diverting loop ileostomy followed by ileostomy closure either early (post-operative days 10-14) or at least 12 weeks after surgery depending on group assignment.
1 surgery visit for restorative proctectomy, 1 to 2 visits for ileostomy closure depending on timing
Duration - 12 months post-restorative proctectomy
Participants are monitored for complications, recovery, bowel function, quality of life, and costs up to 12 months following restorative proctectomy and ileostomy closure.
Multiple visits for assessments at 2, 6, 9, and 12 months post-surgery, and additional visits at 7 and 14 days post-restorative proctectomy
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
S
Sarah Sabboobeh, MSc
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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