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Hernia Repair Using Rectus Fascia Allograft

NCT07326826 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-01-12

No results posted yet for this study

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

Interventions

PROCEDURE

Allogeneic 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 & Collaborators

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Principal Investigators

  • Jiří Froněk, prof., MD, PhD, FRCS · Institute for Clinical and Experimental Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-02-10
Completion
2029-02-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326826 on ClinicalTrials.gov