Ventral Hernia RepairNCT04132986
Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair
An observational study of Ventral Hernia Repair, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ventral Hernia Repair
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Male or female adult patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
Who may be able to join
- Male or female adult patient ( ≥18 years)
- Patient who has agreed to the use of his medical data for the purposes of this research,
- Patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
- Patient who benefited between May 2016 and September 2018 from a biosynthetic mesh
Who cannot join
- Patient who has not consented to the use of her medical data for the purposes of this research,
- Patients who have benefited from the placement of a Phasix® ST biosynthetic mesh in intraperitoneal or Phasix® in retro-muscular prophylaxis,
- Patient under safeguard of justice,
- Patient under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de chirurgie générale et digestive
Strasbourg, 67098
Benoît ROMAIN, MD, 33 3 88 12 72 37, benoit.romain@chru-strasbourg.fr
Benoît ROMAIN, MD
About this study
Official title: Multicenter Descriptive Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair
The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery.
The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months.
The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.
- Conditions
- Ventral Hernia Repair
- Keywords
- Ventral hernia repair, Contaminated surgery, Biosynthetic absorbable mesh, Descriptive study
What is being measured
The primary outcome is the main question the study is designed to answer.
The main criterion will be clinical outcomes : complications and recurrence. It will be expressed in terms of complication according to the Clavien-Dindo classification
Measured: Files analysed retrospectily from May 1st, 2016 to December 31, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Apr 2019
- Primary completionJun 2023 (estimated)
- Study completion30 Jun 2023 (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 Ventral Hernia RepairStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132986
- Sponsor's protocol ID
- 7398
- Status last verified
- Nov 2021
- First submitted
- 14 Oct 2019
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charleux-Muller D, Hurel R, Fabacher T, Brigand C, Rohr S, Manfredelli S, Passot G, Ortega-Deballon P, Dubuisson V, Renard Y, Romain B. Slowly absorbable mesh in contaminated incisional hernia repair: results of a French multicenter study. Hernia. 2021 Aug;25(4):1051-1059. doi: 10.1007/s10029-020-02366-5. Epub 2021 Jan 25.
PubMed 33492554
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Descriptive Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT04132986
- Acronym / sponsor ID
- 7398
- Conditions
- Ventral Hernia Repair
- Keywords
- Ventral hernia repair, Contaminated surgery, Biosynthetic absorbable mesh, Descriptive study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Oct 2019 (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 potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery.
The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months.
The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female adult patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
Key inclusion criteria (4 listed)
- Male or female adult patient ( ≥18 years)
- Patient who has agreed to the use of his medical data for the purposes of this research,
- Patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
- Patient who benefited between May 2016 and September 2018 from a biosynthetic mesh
Key exclusion criteria (4 listed)
- Patient who has not consented to the use of her medical data for the purposes of this research,
- Patients who have benefited from the placement of a Phasix® ST biosynthetic mesh in intraperitoneal or Phasix® in retro-muscular prophylaxis,
- Patient under safeguard of justice,
- Patient under guardianship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The main criterion will be clinical outcomes : complications and recurrence. It will be expressed in terms of complication according to the Clavien-Dindo classification
Time frame: Files analysed retrospectily from May 1st, 2016 to December 31, 2021 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Derived from this study: PubMed 33492554Charleux-Muller D, Hurel R, Fabacher T, Brigand C, Rohr S, Manfredelli S, Passot G, Ortega-Deballon P, Dubuisson V, Renard Y, Romain B. Slowly absorbable mesh in contaminated incisional hernia repair: results of a French multicenter study. Hernia. 2021 Aug;25(4):1051-1059. doi: 10.1007/s10029-020-02366-5. Epub 2021 Jan 25.
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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. This study is not recruiting at the moment.
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 Ventral Hernia Repair, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Dec 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoît ROMAIN, MD (33 3 88 12 72 37, benoit.romain@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main criterion will be clinical outcomes : complications and recurrence. It will be expressed in terms of complication according to the Clavien-Dindo classification (time frame: Files analysed retrospectily from May 1st, 2016 to December 31, 2021 will be examined). 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 NCT04132986, 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 14 Dec 2021.