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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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
137 Previous Clinical Trials
271,926 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
442 Previous Clinical Trials
159,056 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I have the chance to be a volunteer in this clinical experiment?

"This research is looking for 118 individuals afflicted with rectal cancer of between 18 and 90 years old. Additionally, applicants must meet these prerequisites: undergoing a restorative proctectomy by either laparoscopic, robotic, transanal total mesorectal excision or open approach; being an adult aged over 18; passing the negative anastomotic "leak test" via CT scan using rectally administrated water-soluble contrast on postoperative days 7, 8 or 9."

Answered by AI

Is this research effort currently accepting participants?

"On clinicaltrials.gov, this trial is stated to be actively recruiting patients since its inception on February 22nd 2022 and recent revision on August 22nd 2022."

Answered by AI

Is the enrollment criterion for this clinical trial limited to individuals over 20 years old?

"This medical study is accepting adults that are older than 18 and younger than 90."

Answered by AI

How many healthcare centers are currently conducting this experiment?

"There are currently 4 sites that are partaking in this experiment, being Vancouver, London and Montreal. To avoid excessive travel needs, it is suggested to choose the most proximal location if you decide to take part."

Answered by AI

What is the upper limit of enrollees for this research project?

"This research requires 118 volunteers who fit the criteria to be enrolled. Potential participants can register at St. Paul's Hospital, Providence Health Care (Vancouver), and London Health Sciences Centre (London)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Early Ileostomy Closure for Rectal Cancer Patients in North America
Dr. Marylise Boutros 2022. "Early Ileostomy Closure for Rectal Cancer Patients in North America". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027737.
~45 spots leftby Sep 2025
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