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

Condition(s) studied

Investigational drug(s) / intervention(s)

Sac-flap peritonealization of the mesh: The hernial sac is not excised. After reduction of the hernia contents, a broad flap of the sac is preserved on its vascular pedicle. Before the mesh is fixed, the flap is rotated deep to the prosthesis and sutured circumferentially with a slow-absorbable suture to form a continuous 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 periosteum, to the contralateral posterior layer, or with trans-osseous or peri-osteal sutures as anatomy permits - providing soft-tissue coverage and a buttress where fascial fixation is impossible. Hemostasis of the flap is confirmed and a closed-suction drain is placed in the retromuscular space. No additional prosthetic material and no donor site are used.

Retromuscular (sublay) synthetic mesh repair: Open repair through a midline or location-appropriate incision, with reduction of hernia contents and adhesiolysis as required; definition of the fascial defect including the bony margin, with measurement of defect width and length and recording of the European Hernia Society location and size class; development of the retromuscular (retrorectus) plane, with posterior component separation by transversus abdominis release where required to achieve tension-free closure; placement of a flat, medium-weight monofilament polypropylene mesh of standardized type in the retromuscular position with wide overlap and standardized suture fixation; anterior fascial closure of the linea alba where achievable; and closed-suction retromuscular drainage. This intervention is common to both arms and is delivered identically in each.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Composite surgical site occurrence (SSO) — Within 30 days after surgery
  Proportion of participants experiencing one or more components of the composite: surgical site infection (per CDC criteria), seroma, hematoma, skin or soft-tissue necrosis, wound dehiscence, mesh exposure, or enterocutaneous fistula. The outcome is binary (present/absent) at the participant level. It is assessed by independent masked outcome assessors using a structured wound proforma with photographic documentation; each component is also recorded individually, with its date of onset and management, so that components can be analyzed separately and so that the subset requiring procedural intervention can be derived.

Trial sites (1)

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