Hernia Repair Using Rectus Fascia Allograft

Abdominal Wall Hernia Repair With Implantation of an Allogeneic Non-vascularised Rectus Abdominis Fascial Graft: A Pilot Prospective Observational Study

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 Overview

• Status: Not yet recruiting
• Conditions: Abdominal Wall Hernia
• Intervention / Treatment: Procedure: Allogeneic non-vascularized rectus abdominis fascial graft (NVRF)

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Kateřina Lawrie, MD, PhD; Phone Number: +420728137996; Email: lawk@ikem.cz
• Study Contact Backup: Name: Michal Kudla, MD, PhD; Phone Number: +420606407561; Email: mikd@ikem.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection (SSI)	Cumulative incidence of SSI within 90 days after the index surgery (any SSI diagnosed and treated according to institutional practice).	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.	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.	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.	Baseline, 1 month and 12 months after surgery

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine
• Investigators: Principal Investigator: Jiří Froněk, prof., MD, PhD, FRCS, Institute for Clinical and Experimental Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): February 10, 2029

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Estimated): January 8, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: transplant; hernia repair; abdominal wall reconstruction; fascia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal
• Other Study ID Numbers: 48494/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No