Hernia Repair Using Rectus Fascia Allograft

NCT07326826 | Not Yet Recruiting

• 1 other identifier: 48494/25
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Wall Hernia

Keywords

hernia repair; fascia; transplant; abdominal wall reconstruction

Outcome Measures

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).

  12 months after surgery

Secondary Outcomes (4)

• Surgical site infection (SSI)

  Up to 90 days after surgery

• Donor-specific anti-HLA antibodies (DSA)

  Baseline (day of surgery), 3 months, and 12 months

• Direct healthcare costs (public health insurance reimbursements)

  12 months after 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

Interventions

Allogeneic non-vascularized rectus abdominis fascial graft (NVRF) PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Related Publications (1)

• Van De Winkel N, Muylle E, Canovai E, Amin I, Butler A, Vianna R, Selvaggi G, Farinelli P, Gondolesi G, Loinaz C, Justo I, Vilca-Melendez H, Skogsberg Dahlgren U, Herlenius G, Shamsaeefar A, Nikoupour H, Dubois A, Miserez M, D'Hoore A, Venick R, Pirenne J, Ceulemans LJ. Long-term Outcome After Nonvascularized Rectus Fascia Transplantation in Solid Organ Transplantation: A Global Multicenter IIRTA Survey. Transplant Direct. 2025 Jul 24;11(8):e1839. doi: 10.1097/TXD.0000000000001839. eCollection 2025 Aug.

  PMID: 40718051 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiří Froněk, prof., MD, PhD, FRCS

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kateřina Lawrie, MD, PhD

CONTACT

+420728137996; lawk@ikem.cz

Michal Kudla, MD, PhD

CONTACT

+420606407561; mikd@ikem.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, MD, PhD

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): February 10, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01