Incisional HerniaNCT06762561
Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair
An observational study of Incisional Hernia and Aortic Aneurysm, run by Hôpital Fribourgeois at 1 site in Switzerland.
Trial summary
The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia, Aortic Aneurysm
- What is being tested?
- Prophylactic retromuscular mesh reinforcement
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2025to 31 Oct 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult patients who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement at the Fribourg Cantonal Hospital between 2019 and 2024.
Who may be able to join
- Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024
- Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data
- Attendance at a clinical follow-up examination at least one year after the procedure
- General informed consent signed for the use of medical data for research purposes
Who cannot join
- Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data
- Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.
- Patients who did not attend the required clinical follow-up examination at least one year postoperatively.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
HFR Hopitaux Fribourgeois
Villars-sur-Glâne
Melissa Lagger, med. dipl, +41263062608, melissa.lagger@h-fr.ch
Sguinzi Raffaella, PhD, raffaellamaria.sguinzi@h-fr.ch
About this study
Official title: Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study
The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are:
- Does mesh reinforcement reduce the incidence of incisional hernias?
- What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications.
Read more
Participants will:
- Undergo clinical follow-ups and abdominal ultrasounds to detect IH.
- Complete quality-of-life questionnaires (EQ-5D and PROMIS).
- Conditions
- Incisional Hernia, Aortic Aneurysm
- Being tested
- Prophylactic retromuscular mesh reinforcement
- Medical subject headings
- Incisional Hernia, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic retromuscular mesh reinforcementProcedure or surgery
Prophylactic retromuscular mesh placement involves reinforcing the abdominal wall during closure after open abdominal aortic aneurysm (AAA) repair to prevent incisional hernias. This technique creates a retro-muscular space by carefully dissecting the rectus abdominis muscles from the posterior rectus sheath. A self-gripping polyester mesh or composite mesh is placed in this space, extending 4 cm beyond the midline on each side, ensuring tension-free coverage. The mesh is secured at key points, and the rectus sheaths are closed with continuous sutures. This approach leverages the anatomical integrity of the abdominal wall to reduce hernia risk without increasing postoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic mesh reinforcement after open aortic aneurysm repair | Patients who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement at the Fribourg Cantonal Hospital between 2019 and 2024. Receives: Procedure: Prophylactic retromuscular mesh reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incisional hernias
Incisional hernia will be evaluated trough clinical examination and ultrasound assessement
Measured: january-april 2025
Secondary outcomes (5)
Rate of fascial dehiscence
Fascial dehiscence will be searched in the patient's records
Measured: january-april 2025
Rate of seromas
will be searched in the patient's records
Measured: january-april 2025
Rate of surgical site infection
will be searched in the patient's records
Measured: january-april 2025
Rate of hematomas
will be searched in the patient's records
Measured: january-april 2025
Operative time
will be searched in the operation protocols
Measured: january-april 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Incisional 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762561
- Sponsor's protocol ID
- 2348
- Status last verified
- Jun 2025
- First submitted
- 31 Dec 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Endo T, Miyahara K, Shirasu T, Mochizuki Y, Taniguchi R, Takayama T, Hoshina K. Risk Factors for Incisional Hernia After Open Abdominal Aortic Aneurysm Repair. In Vivo. 2023 Nov-Dec;37(6):2803-2807. doi: 10.21873/invivo.13393.
PubMed 37905664Antoniou GA, Muysoms FE, Deerenberg EB. Updated Guideline on Abdominal Wall Closure from the European and American Hernia Societies: Transferring Recommendations to Clinical Practice for Vascular Surgeons. Eur J Vasc Endovasc Surg. 2023 Jun;65(6):774-777. doi: 10.1016/j.ejvs.2023.02.009. Epub 2023 Feb 16. No abstract available.
PubMed 36804613Antoniou GA, Georgiadis GS, Antoniou SA, Granderath FA, Giannoukas AD, Lazarides MK. Abdominal aortic aneurysm and abdominal wall hernia as manifestations of a connective tissue disorder. J Vasc Surg. 2011 Oct;54(4):1175-81. doi: 10.1016/j.jvs.2011.02.065. Epub 2011 Aug 6.
PubMed 21820838DeAngelo N, Perez AJ. Hernia Prevention: The Role of Technique and Prophylactic Mesh to Prevent Incisional Hernias. Surg Clin North Am. 2023 Oct;103(5):847-857. doi: 10.1016/j.suc.2023.04.021. Epub 2023 Jun 9.
PubMed 37709391Franchi M, Ghezzi F, Buttarelli M, Tateo S, Balestreri D, Bolis P. Incisional hernia in gynecologic oncology patients: a 10-year study. Obstet Gynecol. 2001 May;97(5 Pt 1):696-700. doi: 10.1016/s0029-7844(01)01192-9.
PubMed 11339918Sorensen LT, Hemmingsen UB, Kirkeby LT, Kallehave F, Jorgensen LN. Smoking is a risk factor for incisional hernia. Arch Surg. 2005 Feb;140(2):119-23. doi: 10.1001/archsurg.140.2.119.
PubMed 15723991Goodenough CJ, Ko TC, Kao LS, Nguyen MT, Holihan JL, Alawadi Z, Nguyen DH, Flores JR, Arita NT, Roth JS, Liang MK. Development and validation of a risk stratification score for ventral incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am Coll Surg. 2015 Apr;220(4):405-13. doi: 10.1016/j.jamcollsurg.2014.12.027. Epub 2015 Jan 2.
PubMed 25690673Montalti R, Mimmo A, Rompianesi G, Serra V, Cautero N, Ballarin R, De Ruvo N, Cunningham Gerring R, Enrico Gerunda G, Di Benedetto F. Early use of mammalian target of rapamycin inhibitors is an independent risk factor for incisional hernia development after liver transplantation. Liver Transpl. 2012 Feb;18(2):188-94. doi: 10.1002/lt.22445.
PubMed 21987434Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.
PubMed 36026550Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23.
PubMed 38307694Dewulf M, Muysoms F, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, van Bergen L, Berrevoet F, Detry O. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: Five-year Follow-up of a Randomized Controlled Trial. Ann Surg. 2022 Oct 1;276(4):e217-e222. doi: 10.1097/SLA.0000000000005545. Epub 2022 Jun 28.
PubMed 35762612Muysoms FE, Detry O, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, Defraigne JO, Berrevoet F. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial. Ann Surg. 2016 Apr;263(4):638-45. doi: 10.1097/SLA.0000000000001369.
PubMed 26943336Bali C, Papakostas J, Georgiou G, Kouvelos G, Avgos S, Arnaoutoglou E, Papadopoulos G, Matsagkas M. A comparative study of sutured versus bovine pericardium mesh abdominal closure after open abdominal aortic aneurysm repair. Hernia. 2015 Apr;19(2):267-71. doi: 10.1007/s10029-014-1262-4. Epub 2014 May 13.
PubMed 24820007Bevis PM, Windhaber RA, Lear PA, Poskitt KR, Earnshaw JJ, Mitchell DC. Randomized clinical trial of mesh versus sutured wound closure after open abdominal aortic aneurysm surgery. Br J Surg. 2010 Oct;97(10):1497-502. doi: 10.1002/bjs.7137.
PubMed 20603858Timmermans L, Eker HH, Steyerberg EW, Jairam A, de Jong D, Pierik EG, Lases SS, van der Ham AC, Dawson I, Charbon J, Schuhmacher C, Izbicki JR, Neuhaus P, Knebel P, Fortelny R, Kleinrensink GJ, Jeekel J, Lange JF. Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia. Ann Surg. 2015 Feb;261(2):276-81. doi: 10.1097/SLA.0000000000000798.
PubMed 24983993
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06762561
- Acronym / sponsor ID
- 2348
- Conditions
- Incisional Hernia, Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 7 Jan 2025 (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.
The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are:
- Does mesh reinforcement reduce the incidence of incisional hernias?
- What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications.
Participants will:
- Undergo clinical follow-ups and abdominal ultrasounds to detect IH.
- Complete quality-of-life questionnaires (EQ-5D and PROMIS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylactic mesh reinforcement after open aortic aneurysm repair | – | Procedure: Prophylactic retromuscular mesh reinforcementPatients who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement at the Fribourg Cantonal Hospital between 2019 and 2024. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement at the Fribourg Cantonal Hospital between 2019 and 2024.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024
- Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data
- Attendance at a clinical follow-up examination at least one year after the procedure
- General informed consent signed for the use of medical data for research purposes
Key exclusion criteria (3 listed)
- Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data
- Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.
- Patients who did not attend the required clinical follow-up examination at least one year postoperatively.
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 |
|---|---|---|
| Prophylactic retromuscular mesh reinforcementProphylactic retromuscular mesh placement involves reinforcing the abdominal wall during closure after open abdominal aortic aneurysm (AAA) repair to prevent incisional hernias. This technique creates a retro-muscular space by carefully dissecting the rectus abdominis muscles from the posterior rectus sheath. A self-gripping polyester mesh or composite mesh is placed in this space, extending 4 cm beyond the midline on each side, ensuring tension-free coverage. The mesh is secured at key points, and the rectus sheaths are closed with continuous sutures. This approach leverages the anatomical integrity of the abdominal wall to reduce hernia risk without increasing postoperative complications. | Procedure or surgery | Prophylactic mesh reinforcement after open aortic aneurysm repair |
Primary outcome
Rate of incisional hernias
Time frame: january-april 2025
Incisional hernia will be evaluated trough clinical examination and ultrasound assessement
5 secondary outcomes
Rate of fascial dehiscence
Time frame: january-april 2025
Rate of seromas
Time frame: january-april 2025
Rate of surgical site infection
Time frame: january-april 2025
Rate of hematomas
Time frame: january-april 2025
Operative time
Time frame: january-april 2025
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 3 Jun 2025.
- Results publication: PubMed 37905664Endo T, Miyahara K, Shirasu T, Mochizuki Y, Taniguchi R, Takayama T, Hoshina K. Risk Factors for Incisional Hernia After Open Abdominal Aortic Aneurysm Repair. In Vivo. 2023 Nov-Dec;37(6):2803-2807. doi: 10.21873/invivo.13393.
- Results publication: PubMed 36804613Antoniou GA, Muysoms FE, Deerenberg EB. Updated Guideline on Abdominal Wall Closure from the European and American Hernia Societies: Transferring Recommendations to Clinical Practice for Vascular Surgeons. Eur J Vasc Endovasc Surg. 2023 Jun;65(6):774-777. doi: 10.1016/j.ejvs.2023.02.009. Epub 2023 Feb 16. No abstract available.
- Results publication: PubMed 21820838Antoniou GA, Georgiadis GS, Antoniou SA, Granderath FA, Giannoukas AD, Lazarides MK. Abdominal aortic aneurysm and abdominal wall hernia as manifestations of a connective tissue disorder. J Vasc Surg. 2011 Oct;54(4):1175-81. doi: 10.1016/j.jvs.2011.02.065. Epub 2011 Aug 6.
- Results publication: PubMed 37709391DeAngelo N, Perez AJ. Hernia Prevention: The Role of Technique and Prophylactic Mesh to Prevent Incisional Hernias. Surg Clin North Am. 2023 Oct;103(5):847-857. doi: 10.1016/j.suc.2023.04.021. Epub 2023 Jun 9.
- Results publication: PubMed 11339918Franchi M, Ghezzi F, Buttarelli M, Tateo S, Balestreri D, Bolis P. Incisional hernia in gynecologic oncology patients: a 10-year study. Obstet Gynecol. 2001 May;97(5 Pt 1):696-700. doi: 10.1016/s0029-7844(01)01192-9.
- Results publication: PubMed 15723991Sorensen LT, Hemmingsen UB, Kirkeby LT, Kallehave F, Jorgensen LN. Smoking is a risk factor for incisional hernia. Arch Surg. 2005 Feb;140(2):119-23. doi: 10.1001/archsurg.140.2.119.
- Results publication: PubMed 25690673Goodenough CJ, Ko TC, Kao LS, Nguyen MT, Holihan JL, Alawadi Z, Nguyen DH, Flores JR, Arita NT, Roth JS, Liang MK. Development and validation of a risk stratification score for ventral incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am Coll Surg. 2015 Apr;220(4):405-13. doi: 10.1016/j.jamcollsurg.2014.12.027. Epub 2015 Jan 2.
- Results publication: PubMed 21987434Montalti R, Mimmo A, Rompianesi G, Serra V, Cautero N, Ballarin R, De Ruvo N, Cunningham Gerring R, Enrico Gerunda G, Di Benedetto F. Early use of mammalian target of rapamycin inhibitors is an independent risk factor for incisional hernia development after liver transplantation. Liver Transpl. 2012 Feb;18(2):188-94. doi: 10.1002/lt.22445.
- Results publication: PubMed 36026550Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.
- Results publication: PubMed 38307694Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23.
- Results publication: PubMed 35762612Dewulf M, Muysoms F, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, van Bergen L, Berrevoet F, Detry O. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: Five-year Follow-up of a Randomized Controlled Trial. Ann Surg. 2022 Oct 1;276(4):e217-e222. doi: 10.1097/SLA.0000000000005545. Epub 2022 Jun 28.
- Results publication: PubMed 26943336Muysoms FE, Detry O, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, Defraigne JO, Berrevoet F. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial. Ann Surg. 2016 Apr;263(4):638-45. doi: 10.1097/SLA.0000000000001369.
- Individual participant dataSharing planned: Undecided
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia and Aortic Aneurysm, run by Hôpital Fribourgeois at 1 site in Switzerland.
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 4 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Raffaella Sguinzi, PhD (0041263062584, RaffaellaMaria.Sguinzi@h-fr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of incisional hernias (time frame: january-april 2025). 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 NCT06762561, which also lists 28 linked publications.
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 3 Jun 2025.