Early Ileostomy Closure for Rectal Cancer Patients in North America

NCT05027737 | Recruiting

• 1 other identifier: MP-05-2022-2953
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complications

  Comprehensive complication index

  12-months post-restorative proctectomy

Secondary Outcomes (8)

• Complications

  2-, 6-, and 9-months post-restorative proctectomy

• Occurrence of post-operative ileus following ileostomy reversal

  Monitored for from date of ileostomy closure to day of discharge from hospital

• Cost of patient care (in dollars)

  Calculated at 6- and 12-months post restorative proctectomy

• Time to chemotherapy (weeks)

  Starting from restorative proctectomy post-operative day 1 through the course of the study (1 year follow-up)

• Post-operative recovery

  1- and 2-weeks post-restorative proctectomy and diverting loop ileostomy as well as 30 days post-diverting loop ileostomy closure

Study Arms (2)

Early Ileostomy Closure

EXPERIMENTAL

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.

Procedure: Early Ileostomy Closure

Traditional closure (control)

NO INTERVENTION

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 PROCEDURE

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.

Early Ileostomy Closure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Jewish General Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (4)

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Natasha Caminsky, MD

CONTACT

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

Sarah Sabboobeh, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Multi-centre, assessor-blind, parallel-groups (1:1), pragmatic, randomized controlled trial

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 30, 2021
• Study Start: February 22, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

CA (4)