Small Versus Large Bite Closure of Emergency Midline Laparotomy (NCT04098380) | Clinical Trial Compass
UnknownNot Applicable
Small Versus Large Bite Closure of Emergency Midline Laparotomy
Egypt160 participantsStarted 2019-09-21
Plain-language summary
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy.
A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study.
The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.
Who can participate
Age range
16 Years – 70 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:
* Adult patients of both sexes aging less than 70 years old
Exclusion Criteria:
* All procedures which will be performed on elective basis will be excluded
* patients who are pregnant.
* Patients on systemic steroid or chemotherapy
* patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.
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.