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 preserves it as a living, blood-supplied flap, rotates it underneath the mesh, and stitches it in place as a new lining layer that separates the mesh from the bowel and covers the bony edge. The technique uses only the patient's own tissue: no extra mesh, no donor site and no added cost.
One hundred and eighty adults undergoing planned (non-emergency) open repair of a bony-edged complex ventral hernia will be randomly assigned in equal numbers to one of two groups: standard retromuscular (sublay) mesh repair with the added sac flap (90 participants), or standard retromuscular mesh repair alone, with the sac handled in the conventional way (90 participants). Every other step of the operation is the same in both groups.
The main question is whether the sac flap reduces the number of participants who develop any wound or mesh problem in the first 30 days after surgery. This is measured as a composite called a surgical site occurrence, which includes wound infection, seroma, haematoma, skin or soft-tissue death, wound breakdown, mesh exposure and fistula. The trial also compares complications needing a drainage or operative procedure, hernia recurrence at 12 months, overall complication severity, operating time, blood loss, hospital stay, readmission, reoperation, pain, quality of life and death.
Participants, ward and clinic staff, the doctors who assess the wounds, the radiologist who reads the follow-up scans and the trial statistician will not know which operation was performed; only the operating surgeon will. The group assignment is revealed only during the operation, after the surgeon has confirmed that the defect truly has a bony edge and that the sac is suitable for a flap. Participants are followed for 12 months.
Inclusion Criteria:
Exclusion Criteria:
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The operating surgeon cannot be masked, because the intervention is a surgical step. All other parties are masked: the participant; ward and clinic staff; the independent outcome assessors who perform the wound and recurrence evaluations; the radiologist who reads the follow-up imaging; and the trial statistician, who analyzes arms coded A and B. Operative notes that would reveal allocation are stored separately from the assessment record, and an identical dressing and drain regimen is used in both arms so that early wound appearance does not unmask assessors.
Participants undergo standard open retromuscular (sublay) synthetic mesh repair of the bony-edged complex ventral hernia, with posterior component separation by transversus abdominis release where required, PLUS peritonealization of the visceral surface of the mesh with a preserved, pedicled flap of the hernial sac. The sac is not excised. A broad flap is preserved on its vascular pedicle, rotated deep to the prosthesis before mesh fixation, and sutured circumferentially with a slow-absorbable suture to form a continuous autologous neo-peritoneal layer that fully separates the visceral surface of the mesh from the abdominal contents. At the bony margin, the leading edge of the flap is anchored across the bone to provide soft-tissue coverage and a fixation buttress. A closed-suction drain is placed in the retromuscular space.
Participants undergo standard open retromuscular (sublay) synthetic mesh repair of the bony-edged complex ventral hernia, with posterior component separation by transversus abdominis release where required, and conventional handling of the hernial sac: the sac is excised or simply reduced and is not used to cover the mesh. The visceral surface of the mesh is managed by the operating surgeon's standard practice - re-approximation of the posterior layer where feasible, or omental interposition - without an autologous sac neo-peritoneum and without sac-based coverage of the bony edge. Mesh type, fixation method, drainage and all perioperative care are identical to the experimental arm.
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