Hernia Repair Using Rectus Fascia Allograft

Institute for Clinical and Experimental Medicine

Status: Not yet enrolling

Conditions: Abdominal Wall Hernia

Treatments: Procedure: Allogeneic non-vascularized rectus abdominis fascial graft (NVRF)

Study type: Observational

Funder types: Other

Identifiers

NCT07326826

48494/25

Details and patient eligibility

About

Abdominal wall closure in highly complex patients is one of the most difficult tasks in abdominal surgery. Repeated laparotomies, enterocutaneous fistulas, loss of the fascial layer and contaminated operative fields may prevent safe fascial approximation, and closure under high tension can lead to serious complications such as abdominal compartment syndrome. These problems are frequently encountered after intestinal or multivisceral transplantation and are not uncommon after liver transplantation. While component separation, flap techniques and mesh reinforcement are available, standard approaches may be insufficient or inappropriate in extensive or contaminated defects, and synthetic mesh may be contraindicated due to infection risk.

An allogeneic non-vascularized rectus abdominis fascial graft (NVRF) offers a practical alternative for isolated fascial defects with preserved skin coverage. The technique is relatively simple, reproducible, and does not require vascular reconstruction, potentially filling a gap where synthetic mesh is unsuitable. However, current evidence is limited, heterogeneous and largely retrospective.

This pilot prospective observational study will assess the feasibility and outcomes of elective incisional or primary ventral hernia repair using NVRF in (1) solid organ transplant recipients and (2) highly selected patients with exhausted standard abdominal wall reconstruction options and contraindications to synthetic mesh. Key outcomes include 12-month hernia recurrence, 90-day surgical site infection, immunologic response measured by donor-specific anti-HLA antibodies, direct healthcare costs over 12 months, and patient-reported quality of life using the EuraHS-QoL questionnaire.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Solid organ transplant recipients (liver, kidney, pancreas, heart, or combined transplantation) ≥ 6 months post-transplantation with a primary ventral or incisional hernia.
• Non-transplant patients with a complex abdominal wall defect not amenable to currently established reconstructive methods (e.g., mesh repair, flap transposition, component separation).
• ECOG performance status 0-2.
• Written informed consent.

Exclusion criteria

• ECOG performance status 3-4.
• Pregnancy.
• High-dose corticosteroid therapy.