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临床试验/NCT07326826
NCT07326826尚未招募不适用

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

Institute for Clinical and Experimental Medicine0 个研究点目标入组 20 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
Hernia recurrence

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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-
  • Written informed consent.

排除标准

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

结局指标

主要结局

Hernia recurrence

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Institute for Clinical and Experimental Medicine
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jiri Fronek

Professor of Surgery, MD, PhD

Institute for Clinical and Experimental Medicine

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