← Back to Search

Early Ileostomy Closure for Rectal Cancer

N/A
Recruiting
Research Sponsored by Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Adult patients (≥18 years-old)
Must not have
Age-adjusted Charlson Comorbidity Index >6
Inability to speak or comprehend English or French and inability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure
Awards & highlights

Summary

This trial will help determine whether early ileostomy closure (EIC) is safe and feasible for select rectal cancer patients undergoing restorative proctectomy (RP) with a diverting loop ileostomy (DLI) in North America.

Who is the study for?
This trial is for adults over 18 with rectal cancer who've had a specific surgery (restorative proctectomy) and an ileostomy without complications or major health issues. They must have passed a leak test post-surgery, speak English or French, and not be on recent immunosuppressants.
What is being tested?
The study tests if closing the ileostomy early after surgery is safe and beneficial compared to doing it later. It's a randomized-controlled trial in North America focusing on complication severity, quality of life, bowel function, and healthcare costs.
What are the potential side effects?
While the side effects are not explicitly listed here, potential risks may include complications related to early closure such as infection, leakage at the surgical site, blockage or bleeding from the intestine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery for rectal cancer that involved creating a temporary ileostomy.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My health conditions score is above 6 on the Charlson index.
Select...
I can speak and understand English or French and can give informed consent.
Select...
I had another major surgery at the same time as my main operation.
Select...
I have had serious complications after my rectum surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Bowel function
Complications
Cost of patient care (in dollars)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Ileostomy ClosureExperimental Treatment1 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 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.
Group II: Traditional closure (control)Active Control1 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.

Find a Location

Who is running the clinical trial?

Jewish General HospitalLead Sponsor
140 Previous Clinical Trials
278,450 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
463 Previous Clinical Trials
165,035 Total Patients Enrolled

Media Library

Early Ileostomy Closure Clinical Trial Eligibility Overview. Trial Name: NCT05027737 — N/A
Colorectal Cancer Research Study Groups: Early Ileostomy Closure, Traditional closure (control)
Colorectal Cancer Clinical Trial 2023: Early Ileostomy Closure Highlights & Side Effects. Trial Name: NCT05027737 — N/A
Early Ileostomy Closure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027737 — N/A
~31 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top