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Hernia Sac Flap Coverage of Mesh in Bony-Edged Ventral Hernia Repair

RecruitingNAAges 18 Years - 75 YearsAllMinia University
NCT07720154 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This trial asks whether covering the inner, bowel-facing surface of a hernia mesh with a flap of the patient's own hernia sac improves healing after repair of a complex ventral (abdominal wall) hernia in which one edge of the defect is bone - for example hernias next to the breastbone and ribs, above the pubic bone, or at the iliac crest. In these "bony-edged" hernias the mesh is both hardest to fix and hardest to cover. There is no fascia on the bony side for the surgeon to stitch the mesh to, and the lining layer of the abdomen cannot be closed underneath the mesh because the plane that carries it stops at the bone. The mesh may therefore be left in contact with the bowel, which can lead to dense adhesions, mesh erosion, chronic pain and, rarely, a fistula. Normally the hernia sac - the thin membrane that lines the hernia - is cut away and discarded. In this trial the surgeon instead

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📋 Eligibility rules (as published)
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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What it tests

  • Sac-flap peritonealization of the mesh
  • Retromuscular (sublay) synthetic mesh repair
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Where

1 site
Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University
Minya, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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