Abdominal Wall HerniaNCT07326826
Hernia Repair Using Rectus Fascia Allograft
An observational study of Abdominal Wall Hernia, run by Institute for Clinical and Experimental Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Hernia
- What is being tested?
- Allogeneic non-vascularized rectus abdominis fascial graft (NVRF)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 10 Feb 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- ECOG performance status 3-4.
- Pregnancy.
- High-dose corticosteroid therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Abdominal Wall Hernia
- Being tested
- Allogeneic non-vascularized rectus abdominis fascial graft (NVRF)
- Keywords
- hernia repair, fascia, transplant, abdominal wall reconstruction
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic non-vascularized rectus abdominis fascial graft (NVRF)Procedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after surgery
Secondary outcomes (4)
Surgical site infection (SSI)
Cumulative incidence of SSI within 90 days after the index surgery (any SSI diagnosed and treated according to institutional practice).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion10 Feb 2028 (estimated)
- Study completion10 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jiri Fronek, Institute for Clinical and Experimental Medicine
- Investigators
- Jiří Froněk, prof., MD, PhD, FRCS, Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326826
- Sponsor's protocol ID
- 48494/25
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 40718051
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Hernia Repair With Implantation of an Allogeneic Non-vascularised Rectus Abdominis Fascial Graft: A Pilot Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07326826
- Acronym / sponsor ID
- 48494/25
- Conditions
- Abdominal Wall Hernia
- Keywords
- hernia repair, fascia, transplant, abdominal wall reconstruction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 10 Feb 2028 (estimated)
- Study completion
- 10 Feb 2029 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- ECOG performance status 3-4.
- Pregnancy.
- High-dose corticosteroid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | – |
Primary outcome
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).
4 secondary outcomes
Surgical site infection (SSI)
Time frame: Up to 90 days after surgery
Donor-specific anti-HLA antibodies (DSA)
Time frame: Baseline (day of surgery), 3 months, and 12 months
Direct healthcare costs (public health insurance reimbursements)
Time frame: 12 months after surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 40718051Van 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiří Froněk, prof., MD, PhD, FRCS principal investigator
Institute for Clinical and Experimental Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wall Hernia, run by Institute for Clinical and Experimental Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kateřina Lawrie, MD, PhD (+420728137996, lawk@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07326826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.