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New keyhole surgery aims to fix stoma hernias with fewer comebacks
NCT ID NCT06474403
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new keyhole surgery technique for parastomal hernia, a common complication after stoma creation. The procedure places a mesh outside the abdominal cavity to reinforce the area, potentially reducing adhesions and recurrence. Researchers will compare outcomes in 50 patients against the standard open surgery approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- laparoscopic total extraperitoneal (TEP) parastomal hernia repair with mesh
- What this could lead to
- If successful, this could offer a safer, less invasive surgical option for parastomal hernia repair with faster recovery and lower recurrence rates.
- What could go wrong
- This is a small, early-stage study with only 50 participants and short follow-up. The technique may not prove better than existing methods, and risks like infection or hernia recurrence remain.
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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients with a confirmed diagnosis of parastomal hernia post-stoma creation surgery; 2. Symptomatic hernias requiring surgical intervention; 3. Able to undergo the surgical approach under general anesthesia; 4. Patients who can provide informed consent. Non-Inclusion Criteria: Patients with contraindications to laparoscopic surgery, such as uncontrolled coagulopathies, severe cardiorespiratory conditions, or extensive intra-abdominal adhesions are excluded. Those with ongoing peritonitis, incarcerated hernias requiring urgent care, or malignancy at the hernia site are also excluded. Exclusion Criteria: * Patients unwilling to provide informed consent; * Patients with a life expectancy less than the study follow-up period; * Patients who have previously undergone other types of hernia repair, which could confound the operative and postoperative outcomes being measured.
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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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S.V. Ochapovsky Regional Clinical Hospital #1
RECRUITINGKrasnodar, 350040, Russia
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