Hernia Repair Using Rectus Fascia Allograft

N/ANot Yet RecruitingNCT07326826

Institute for Clinical and Experimental Medicine20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Abdominal Wall Hernia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hernia recurrence

Cumulative incidence of hernia recurrence after the index hernia repair with NVRF (clinical and/or imaging-confirmed recurrence as per routine follow-up).

Time frame: 12 months after surgery

Secondary Outcomes

Surgical site infection (SSI)

Cumulative incidence of SSI within 90 days after the index surgery (any SSI diagnosed and treated according to institutional practice).

Time frame: Up to 90 days after surgery

Donor-specific anti-HLA antibodies (DSA)

Presence at baseline, de novo development, and change at 3 months, and 12 months after surgery.

Time frame: Baseline (day of surgery), 3 months, and 12 months

Direct healthcare costs (public health insurance reimbursements)

Direct reimbursements associated with the index hospitalization for surgery and subsequent follow-up care over 12 months related to the surgery.

Time frame: 12 months after surgery

Patient-reported quality of life assessed using the European Hernia Society Quality of Life Questionnaire (EuraHS-QoL)

European Hernia Society Quality of Life Questionnaire is a disease-specific instrument evaluating pain, restriction of activities, and cosmetic discomfort. The total score ranges from 0 to 90, with higher scores indicating worse quality of life.

Time frame: Baseline, 1 month and 12 months after surgery