CompletedNot Applicable

Impact of a Bridge Device on the Loop Ileostomy

France166 participantsStarted 2016-05-09

Plain-language summary

During the creation of an ileostomy, a bridge device is systematically placed in an aim to reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to justify this issue. Moreover the placement of a bridge device increases the difficulty of nurse cares and is associated with its own morbidity.

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: * colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease) * requiring elective surgery with an ileostomy * patient having given his consent before the enrollment Exclusion Criteria: * patient with early closure of the stoma (within 10 days after the colorectal surgery) * long term corticoids * emergency surgery * history of stoma in the side of the stoma placement planned for the study * BMI \>50 * No signature of the consent to participate in the study * Physical or mental state not allowing participation in the study * Contraindication to surgery * ASA classification (American Society of Anesthesiologists) IV-V or life expectancy \<48h * Pregnancy or breastfeeding * Patient under guardianship or guardianship or patient deprived of liberty by a judicial or administrative decision (in accordance with articles L1121-6 and L1121-8 of the Public Health Code) * Minor patient * Patient without social protection Peroperative exclusion criteria: * no anastomosis * no ileostomy * Spontaneous stomal retraction

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

absence of postoperative morbidity

Timeframe: two months after the surgery

Trial details

NCT IDNCT02756273

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-09

View on ClinicalTrials.gov More Elective Colorectal Surgery trials