Early closure of ileostomy for rectal cancer patients
Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)
This study is testing if closing an ileostomy earlier after rectal cancer surgery can be safe and help patients recover better compared to the usual longer wait time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Jewish General Hospital Academic / other |
| Locations | 4 sites (Vancouver, British Columbia and 3 other locations) |
| Trial ID | NCT05027737 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the safety and feasibility of early ileostomy closure (EIC) in rectal cancer patients who have undergone restorative proctectomy and created a diverting loop ileostomy. Eligible adults will be randomized into two groups: one receiving EIC within 10-14 days post-surgery and the other undergoing standard closure after 12 weeks. The primary focus is to compare the severity of complications between the two approaches, while secondary outcomes will assess recovery, bowel function, and quality of life over a year. The study seeks to identify suitable candidates for EIC and potentially change clinical practice in North America.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone restorative proctectomy with a diverting loop ileostomy for rectal cancer and have passed a negative anastomotic leak test.
Not a fit: Patients with significant comorbidities, recent major surgeries, or complications following surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and quality of life for rectal cancer patients by reducing the duration of ileostomy.
How similar studies have performed: Previous studies in Europe have shown promising results for early ileostomy closure, supporting the need for this large-scale trial in North America.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vancouver, British Columbia and 3 other locations
- 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, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Natasha Caminsky, MD
- Email: natasha.caminsky@mail.mcgill.ca
- Phone: 514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.