RecruitingNot ApplicableNCT05027737

Early Ileostomy Closure for Rectal Cancer Patients in North America

Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)


Sponsor

Jewish General Hospital

Enrollment

118 participants

Start Date

Feb 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial asks whether it is safe to close a temporary ileostomy (a bag attached to a loop of bowel after rectal cancer surgery) earlier than usual — at about 7–9 days after surgery rather than waiting months — if a CT scan shows the bowel connection is healing well. **You may be eligible if...** - You are 18 or older - You had rectal cancer surgery that included creation of a temporary ileostomy (diverting loop) - Your CT scan on post-operative day 7, 8, or 9 showed no leak at the bowel connection **You may NOT be eligible if...** - You received immune-suppressing medications within 6 weeks of surgery - You have significant other health problems (high Charlson Comorbidity Index score) - You had another major surgical procedure at the same time - You had major surgical complications after the rectal surgery - You are unable to communicate in English or French and cannot give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEarly Ileostomy Closure

Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo standardized reversal of their diverting loop ileostomy (stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia) between post-operative days 10-14.


Locations(4)

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

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NCT05027737


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