Early Ileostomy Closure for Rectal Cancer Patients in North America (NCT05027737)
Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Paul's Hospital, Providence Health Care — Vancouver, British Columbia
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
- Early Ileostomy Closure (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- St. Paul's Hospital, Providence Health Care — Vancouver, British Columbia
- London Health Sciences Centre — London, Ontario
- Jewish General Hospital — Montreal, Quebec
- McGill University Health Centre — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (514) 340-8222
Email: natasha.caminsky@mail.mcgill.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.