Early Ileostomy Closure for Rectal Cancer Patients in North America

Recruiting now · Not applicable

Conditions studied: Ileostomy - Stoma, Rectal Cancer

In brief

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.

Key facts

Study ID

NCT05027737

Run by

Jewish General Hospital

People needed

118

Starts

2022-02-22

Expected to finish

2026-09-01

Last updated by the study team

2022-08-23

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult (≥18 years-old) patients
• Underwent restorative proctectomy by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with creation of a diverting loop ileostomy for the treatment of rectal cancer
• Negative anastomotic "leak test" via CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9.

You may not qualify if…

• Peri-operative immunosuppression (within 6 weeks of surgery date);
• Age-adjusted Charlson Comorbidity Index >6;
• Other major surgery during the index operation;
• Any major complications (Clavien Dindo Grade III or greater) following restorative proctectomy;
• Inability to speak or comprehend English or French and inability to give informed consent.

Where it is running

• St. Paul's Hospital, Providence Health Care — Vancouver, British Columbia, Canada (enrolling)
• London Health Sciences Centre — London, Ontario, Canada (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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