Hernia Repair Using Rectus Fascia Allograft
ConditionAbdominal Wall Hernia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute for Clinical and Experimental Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
ECOG performance status 3-4.
Pregnancy.
High-dose corticosteroid therapy.
Trial population
Adult patients (≥18 years) undergoing elective incisional or primary ventral hernia repair with implantation of an allogeneic non-vascularized rectus abdominis fascial graft (NVRF). Eligible participants include solid organ transplant recipients at least 6 months post-transplant (liver, kidney, pancreas, heart, or combined transplants) and highly selected non-transplant patients with complex abdominal wall fascial defects not amenable to standard reconstruction (e.g., mesh repair, flap transposition, component separation) or with contraindications to synthetic mesh. Participants must provide written informed consent and have ECOG performance status 0-2. Pregnant patients, patietns with performance status ECOG 3-4, and on high-dose corticosteroid therapy are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Allogeneic non-vascularized rectus abdominis fascial graft (NVRF)
Procedure/SurgeryElective 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
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 months3
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 surgery4
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 surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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