CompletedNot Applicable

Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus?

Canada101 participantsStarted 2016-12-01

Plain-language summary

Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy undergoes a series of functional and structural changes. It has been hypothesized that these changes may contribute to the development of postoperative ileus, and that stimulating the distal limb of a loop ileostomy prior to closure may functionally prepare the excluded bowel for intestinal transit. The purpose of the multicenter, randomized controlled trial is to determine the impact of preoperative stimulation of the distal limb of a loop ileostomy on postoperative ileus.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients will have undergone an anterior or low-anterior resection for malignant or benign disease with a protective loop ileostomy by a board-certified colorectal surgeon or surgical oncologist at one of the involved sites. Exclusion Criteria: * Patients with a protective ileostomy following colonic resection for Crohn's disease will be excluded from entering the study, as well as patients from whom clear and informed consent cannot be obtained.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with postoperative ileus

Timeframe: Patients will be followed for the duration of hospital stay until discharge, about 30 days

Postoperative length of stay

Timeframe: Patients will be followed for the duration of hospital stay until discharge, about 30 days

Trial details

NCT IDNCT02559635

SponsorJewish General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-18

View on ClinicalTrials.gov More Postoperative Ileus trials