A stitch in time: could a simple suture change cut colostomy hernia risk in half?
NCT ID NCT06674187
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
Parastomal hernia is a common and troublesome complication after colostomy surgery, affecting up to half of patients. This trial tests whether a modified stitching technique, called mesenteric molding suturing, can better support the stoma and reduce hernia formation compared to the standard approach. About 234 adults undergoing colostomy will be randomly assigned to one of the two techniques and followed for a year. The goal is to see if this simple change during surgery can make a meaningful difference in patients' long-term outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a surgical technique called mesenteric molding suturing
- What this could lead to
- If effective, this simple change in surgical technique could become a standard way to prevent parastomal hernia, reducing pain and repeat surgeries for many patients.
- What could go wrong
- This is a single-center trial, and the technique may not work for all patients or may have unforeseen complications. Results need confirmation in larger, broader studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 234 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older. * Patients requiring colostomy surgery. * Ability to provide written informed consent. * Expected survival of more than one year. * No severe comorbidities such as heart, lung, liver, or kidney dysfunction. Exclusion Criteria: * Pregnant or breastfeeding women. * History of major abdominal surgery that could affect the development of PSH. * Mental illness that impairs understanding of the study content and ability to give informed consent. * Patients receiving immunosuppressive therapy or chemotherapy.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Affiliated Hospital of Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210029, China
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