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Can a flap made from the hernia sac itself prevent mesh complications?

NCT ID NCT07720154

Disease control Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This trial tests whether preserving the hernia sac as a living flap and stitching it under the mesh can reduce wound and mesh problems after complex ventral hernia repair where the defect has a bony edge. Half of the 180 participants will receive the standard repair plus the sac flap; the other half will receive standard repair alone. The main question is whether the flap lowers the rate of surgical site occurrences within 30 days, such as infection, seroma, or mesh exposure.

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 procedure that uses the patient's own hernia sac as a living flap to cover the mesh
What this could lead to
If successful, this technique could lower the risk of wound infections, seromas, and mesh-related complications after complex hernia surgery, without added cost or donor tissue.
What could go wrong
This is a single-center trial with 180 participants, so results may not apply broadly. The flap may not always be usable, and the procedure adds complexity to the operation.

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

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

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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. * Elective open repair planned for a complex ventral hernia (primary or incisional) in which at least one margin of the fascial defect is formed by bone - that is, a subxiphoid or costal-margin, suprapubic, or iliac or lumbar location - confirmed on cross-sectional imaging (CT or MRI) and at operation. * A hernial sac of sufficient quality and surface area to raise a pedicled flap adequate to cover the planned mesh, as judged at operation. * Planned retromuscular (sublay) synthetic mesh repair, with or without posterior component separation (transversus abdominis release). * Able to give written informed consent and to attend scheduled follow-up for 12 months. Exclusion Criteria: * Emergency or urgent operation (incarceration with strangulation, obstruction, or perforation). * Active intra-abdominal infection, or a contaminated or dirty operative field (CDC wound class III-IV) at the time of randomization. * Planned use of biologic or composite intraperitoneal mesh, or a bridged (non-fascial-closure) repair as the primary plan. * Hernial sac absent, destroyed, densely scarred, or too small to raise a viable covering flap. * Concurrent bowel resection or stoma creation expected to alter the wound-contamination class. * ASA physical status V. * Life expectancy less than 12 months, or active malignancy under treatment with anticipated short survival. * Pregnancy. * Inability or unwillingness to provide informed consent or to comply with follow-up

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Conditions

The condition(s) this trial relates to.

Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Postoperative Complications Seroma Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal hernia Complex ventral hernia Incisional hernia Postoperative complications SEROMA Surgical site infection Ventral hernia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University

    RECRUITING

    Minya, Minya Governorate, 61519, Egypt

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