Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal. (NCT07573423) | Clinical Trial Compass
CompletedNot Applicable
Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal.
Pakistan252 participantsStarted 2020-06-22
Plain-language summary
This study is a randomized controlled trial designed to compare two commonly used skin closure techniques-linear closure and purse-string closure-after loop ileostomy reversal surgery. Surgical site infection (SSI) is one of the most frequent complications following stoma closure, leading to increased patient discomfort, prolonged hospital stay, and higher healthcare costs.
In this trial, eligible adult patients undergoing elective loop ileostomy reversal are randomly assigned to either linear skin closure or purse-string skin closure. The purse-string technique leaves a small central opening that allows drainage, which may reduce infection risk, whereas linear closure involves complete approximation of the wound edges.
All patients are managed according to standard hospital protocols and are followed during their hospital stay and for 30 days after surgery. The primary outcome is the occurrence of surgical site infection. Secondary outcomes include length of hospital stay and operative time.
The purpose of this study is to determine which closure technique provides better outcomes in terms of reducing postoperative infections and improving recovery. The findings may help guide surgeons in selecting the most effective and safe method for skin closure after ileostomy reversal.
Who can participate
Age range
20 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:
* Patients aged 20 to 70 years
* Both male and female patients
* Patients undergoing elective loop ileostomy reversal
* American Society of Anesthesiologists (ASA) physical status I-II
* Patients who provide informed consent
Exclusion Criteria:
* Patients with active stoma site infection (e.g., fever with total leukocyte count \>11,000/mm³)
* Patients not planned for ileostomy reversal
* Patients with severe comorbid conditions (ASA III or above)
* Patients unwilling to participate in the study
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.
1This trial compared two different ways of closing the skin after ileostomy reversal — a linear cut versus a purse string technique — and measured which one led to fewer wound infections, so can you tell me which method you personally use and whether the results from this study would influence how you'd close my skin?
2Since this trial has already completed, have the results been published yet, and if so, did one closure technique show a meaningfully lower infection rate that might affect my risk after reversal surgery?
3Surgical site infections after ileostomy reversal can delay recovery and require extra treatment — based on what this trial found, is there a preferred closure method you'd recommend for my specific situation, such as my body type, weight, or overall health?
4Are there other factors beyond skin closure technique — like my nutritional status, how long I've had the ileostomy, or the original reason it was created — that might matter more for my infection risk than which stitching method is used?
5If I'm approaching the point where my ileostomy could be reversed, would it be worth waiting to see the published findings from this completed trial before scheduling surgery, or is that unlikely to change the approach you'd recommend for me?
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.