Recruiting

Observational Study

Sponsor:

Jewish General Hospital

Code:

NCT05027737

Conditions

Ileostomy - Stoma

Rectal Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Early Ileostomy Closure

Study Details

Brief 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.

Conditions

Ileostomy - Stoma

Rectal Cancer

Study ID

NCT05027737

Start date

Feb 22, 2022

Status verified date

Aug, 2022

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Complications [ Time Frame: 12-months post-restorative proctectomy ]

Central Contacts and Locations

Central contacts

Natasha Caminsky, MD

514-340-8222natasha.caminsky@mail.mcgill.ca

Sarah Sabboobeh, MSc

514-340-8222sarah.sabboobeh@ladydavis.ca

Locations

St. Paul's Hospital, Providence Health Care

Recruiting

Vancouver, British Columbia, Canada

Contacts

Natasha Caminsky, MD

514-340-8222natasha.caminsky@mail.mcgill.ca

Amandeep Ghuman, MD, MPH, FRCSC

604-806-8860aghuman@providencehealth.bc.ca

Principal Investigator:

Amandeep Ghuman, MD, MPH, FRCSC

London Health Sciences Centre

Recruiting

London, Ontario, Canada

Contacts

Natasha Caminsky, MD

514-340-8222natasha.caminsky@mail.mcgill.ca

Nawar AlKhamesi, MD

Nawar.Alkhamesi@lhsc.on.ca

Principal Investigator:

Nawar AlKhamesi, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T1E2

Contacts

Sarah Sabboobeh, MSc

514-340-8222sarah.sabboobeh@ladydavis.ca

Natasha Caminsky, MD

natasha.caminsky@mail.mcgill.ca

Principal Investigator:

Marylise Boutros, MD

McGill University Health Centre

Recruiting

Montréal, Quebec, Canada

Contacts

Natasha Caminsky, MD

514-340-8222natasha.caminsky@mail.mcgill.ca

Marie Demian, MSc

mariedemian@gmail.com

Principal Investigator:

Sender Liberman, MD

More Information

Sponsor

Jewish General Hospital

Last update posted

Aug 23, 2022

Last verified

Aug, 2022

Keywords

  • Early ileostomy closure
  • Comprehensive complication index
  • Bowel function
  • Quality of life
  • Recovery
  • Cost

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2022-08-23.