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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
St. Paul's Hospital, Providence Health Care
RECRUITING
Vancouver
Contact Information
Primary
Natasha Caminsky, MD
natasha.caminsky@mail.mcgill.ca
514-340-8222
Backup
Sarah Sabboobeh, MSc
sarah.sabboobeh@ladydavis.ca
514-340-8222
Time Frame
Start Date: 2022-02-22
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 118
Treatments
Experimental: 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.
No_intervention: Traditional closure (control)
Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo a standardized reversal of their diverting loop ileostomy. The latter will be performed with a stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia and will be performed no earlier than 12 weeks following their index surgery.
Related Therapeutic Areas
Sponsors
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
Leads: Jewish General Hospital

This content was sourced from clinicaltrials.gov