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NCT Number: NCT07326826

Hernia Repair Using Rectus Fascia Allograft

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Hernia recurrence

    Time frame: 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 outcomes

  1. Surgical site infection (SSI)

    Time frame: 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).

  2. Donor-specific anti-HLA antibodies (DSA)

    Time frame: 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.

  3. Direct healthcare costs (public health insurance reimbursements)

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kateřina Lawrie, MD, PhD

CONTACT

[email protected]

+420728137996

Michal Kudla, MD, PhD

CONTACT

[email protected]

+420606407561

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 8, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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