Abdominal Wall Hernia
Conditions
Keywords
hernia repair, fascia, transplant, abdominal wall reconstruction
Brief summary
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.
Interventions
PROCEDUREAllogeneic non-vascularized rectus abdominis fascial graft (NVRF)
Elective incisional or primary ventral hernia repair with implantation of an allogeneic, non-vascularized rectus abdominis fascial graft (NVRF) to bridge/reinforce the abdominal wall fascial defect. The graft is prepared and implanted according to institutional standard procedures for tissue allografts, no vascular anastomosis is performed.
Sponsors
Institute for Clinical and Experimental Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | 12 months after surgery | Cumulative incidence of hernia recurrence after the index hernia repair with NVRF (clinical and/or imaging-confirmed recurrence as per routine follow-up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection (SSI) | Up to 90 days after surgery | Cumulative incidence of SSI within 90 days after the index surgery (any SSI diagnosed and treated according to institutional practice). |
| Donor-specific anti-HLA antibodies (DSA) | Baseline (day of surgery), 3 months, and 12 months | Presence at baseline, de novo development, and change at 3 months, and 12 months after surgery. |
| Direct healthcare costs (public health insurance reimbursements) | 12 months after surgery | Direct reimbursements associated with the index hospitalization for surgery and subsequent follow-up care over 12 months related to the surgery. |
| Patient-reported quality of life assessed using the European Hernia Society Quality of Life Questionnaire (EuraHS-QoL) | Baseline, 1 month and 12 months after surgery | 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. |
Contacts
Primary ContactKateřina Lawrie, MD, PhD
Backup ContactMichal Kudla, MD, PhD
Outcome results
None listed