[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618069":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":7,"responsibleParty":27,"collaborators":7,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":7,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":7,"enrollmentInfo":39,"targetDuration":42,"studyType":43,"phases":7,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":52,"whyStopped":7,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":7},{"fullName":5,"class":6},"Institute for Clinical and Experimental Medicine","OTHER_GOV",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"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\u002Freinforce the abdominal wall fascial defect. The graft is prepared and implanted according to institutional standard procedures for tissue allografts, no vascular anastomosis is performed.",[14],{"name":15,"affiliation":5,"role":16},"Jiří Froněk, prof., MD, PhD, FRCS","PRINCIPAL_INVESTIGATOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"Kateřina Lawrie, MD, PhD","CONTACT","+420728137996","lawk@ikem.cz",{"name":24,"role":20,"phone":25,"phoneExt":7,"email":26},"Michal Kudla, MD, PhD","+420606407561","mikd@ikem.cz",{"type":16,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Jiri Fronek","Professor of Surgery, MD, PhD","100618069","hernia-repair-using-rectus-fascia-allograft-100618069",false,"NCT07326826","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","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Solid organ transplant recipients (liver, kidney, pancreas, heart, or combined transplantation) ≥ 6 months post-transplantation with a primary ventral or incisional hernia.\n* Non-transplant patients with a complex abdominal wall defect not amenable to currently established reconstructive methods (e.g., mesh repair, flap transposition, component separation).\n* ECOG performance status 0-2.\n* Written informed consent.\n\nExclusion Criteria:\n\n* ECOG performance status 3-4.\n* Pregnancy.\n* High-dose corticosteroid therapy.","ALL","18 Years",{"count":40,"type":41},20,"ESTIMATED","12 Months","OBSERVATIONAL","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.\n\nAn 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.\n\nThis 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.",[46],"Abdominal Wall Hernia",[48,49,50,51],"hernia repair","fascia","transplant","abdominal wall reconstruction","NOT_YET_RECRUITING","2026-01-08",{"date":55,"type":56},"2026-01-12","ACTUAL",{"date":58,"type":41},"2026-02-01",{"date":60,"type":41},"2029-02-10",{"name":5,"class":6}]