Hernia Sac Flap Coverage of Mesh in Complex Bony-Edged Ventral Hernias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study focuses on open, retromuscular repair of complex ventral hernias where a bony edge prevents standard closure. The intervention uses a pedicled hernia sac flap to cover the mesh, aiming to reduce adhesions, erosion, and chronic pain while supporting safer mesh integration. Eligible participants are adults with bone-margin hernias planned for sublay mesh repair, assessed by imaging and during surgery. The trial compares standard sac handling to sac-preservation flap peritonealization of the mesh as a protective layer. Follow-up spans 12 months to monitor healing, complications, and hernia recurrence.

Why it matters

Who can join: the full rules

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

Where it's running

• Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University
  Minya, Minya Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh K Saleh, MD
• Email: salehkhairy@mu.edu.eg
• Phone: 01201765401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.