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RECRUITING
NCT05027737
NA

Early Ileostomy Closure for Rectal Cancer Patients in North America

Sponsor: Jewish General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2022-02-22

Completion Date

2026-09-01

Last Updated

2022-08-23

Healthy Volunteers

No

Interventions

PROCEDURE

Early 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