Ventral HerniaNCT03590184
Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses
An observational study of Ventral Hernia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. It is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2018to Jul 2019
- 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
- All sexes
- Adult, Older adult
Study population: - emergency or planned surgery for an abdominal wall reconstruction, in the context of a contaminated surgery (mVHWG grade 3) at the CHU Strasbourg Hautepierre
Who may be able to join
- over 18 years old
- Patient who has consented to the use of her medical data for research purposes.
- emergency or planned surgery for an abdominal wall reconstruction, in the context of a contaminated surgery (mVHWG grade 3) at the CHU Strasbourg Hautepierre
- use of biological type (Cellis®, Xenmatrix®, Strattice®) or biosynthetic (Phasix®) parietal prostheses
Who cannot join
- Refusal of the patient to participate in the study
- prosthesis placed prophylactically, subcutaneously, endoscopically, for bridge
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie générale et digestive
Strasbourg, 67098
Cécile BRIGAND, MD, PhD, 33 3 88 12 72 26, Cecile.brigand@chru-strasbourg.fr
Diane Muller, 33 3 88 12 72 26, diane.muller@chru-strasbourg.fr
About this study
Official title: Cost-effectiveness Analysis Associated With the Use of Resorbable Biosynthetic Parietal Prostheses Compared to Biological Prostheses in Contaminated (mVHWG Grade 3) Abdominal Wall Reconstruction
Eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. It is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. At present, if there is no debate on the type of prosthesis to implant in case of clean surgery: it is a synthetic prosthesis. But in the case of contaminated surgery (modified Ventral Hernia Working Group grade 3), there is no consensus.
Since the 1990s, biological prostheses have been recommended, but they represent significant expenses for health facilities. They are very numerous, and their prices vary between 3 000 € and 12 000 €. The choice is therefore difficult for the surgeon.
Read more
In 2016 the Strasbourg University Hospital general surgery team made the choice to use biosynthetic prostheses. This attitude does not seem consensual and is not based on any recommendations at present, either in France or internationally. The homogenization of practices requires the availability of clinical and medico-economic data, particularly in view of the price differences that exist between different types of prostheses.
The main objective of this study will be to compare the use of biosynthetic prostheses with biological prostheses in the treatment of curative surgical treatment of mVHWG grade 3 incisional hernias in terms of cost and serious complications at 6 months.
The secondary objective of the study will be to estimate the number of early recurrences at 6 months avoided, thanks to the use of biosynthetic prostheses compared to biological prostheses.
- Conditions
- Ventral Hernia
- Keywords
- Abdominal wall repair, Infection, Biologic mesh, Biosynthetic mesh, Cost-effectiveness
- Medical subject headings
- Hernia, Ventral, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with a biological prosthesis | patients who have received a biological prosthesis | |
| patients with a biosynthetic resorbable prosthesis | patients who have received a biosynthetic resorbable prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness analysis
Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses
Measured: 6 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 posted18 Jul 2018
- Study start1 Jul 2018
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (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 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 114 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
- NCT03590184
- Sponsor's protocol ID
- 7126
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charleux-Muller D, Romain B, Boisson C, Velten M, Brigand C, Lejeune C. Cost-effectiveness analysis of resorbable biosynthetic mesh in contaminated ventral hernia repair. J Visc Surg. 2022 Aug;159(4):279-285. doi: 10.1016/j.jviscsurg.2021.06.001. Epub 2021 Jun 9.
PubMed 34116953
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis Associated With the Use of Resorbable Biosynthetic Parietal Prostheses Compared to Biological Prostheses in Contaminated (mVHWG Grade 3) Abdominal Wall Reconstruction
- ClinicalTrials.gov ID
- NCT03590184
- Acronym / sponsor ID
- 7126
- Conditions
- Ventral Hernia
- Keywords
- Abdominal wall repair, Infection, Biologic mesh, Biosynthetic mesh, Cost-effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 18 Jul 2018 (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.
Eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. It is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. At present, if there is no debate on the type of prosthesis to implant in case of clean surgery: it is a synthetic prosthesis. But in the case of contaminated surgery (modified Ventral Hernia Working Group grade 3), there is no consensus.
Since the 1990s, biological prostheses have been recommended, but they represent significant expenses for health facilities. They are very numerous, and their prices vary between 3 000 € and 12 000 €. The choice is therefore difficult for the surgeon.
In 2016 the Strasbourg University Hospital general surgery team made the choice to use biosynthetic prostheses. This attitude does not seem consensual and is not based on any recommendations at present, either in France or internationally. The homogenization of practices requires the availability of clinical and medico-economic data, particularly in view of the price differences that exist between different types of prostheses.
The main objective of this study will be to compare the use of biosynthetic prostheses with biological prostheses in the treatment of curative surgical treatment of mVHWG grade 3 incisional hernias in terms of cost and serious complications at 6 months.
The secondary objective of the study will be to estimate the number of early recurrences at 6 months avoided, thanks to the use of biosynthetic prostheses compared to biological prostheses.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with a biological prosthesis | – | –patients who have received a biological prosthesis |
| patients with a biosynthetic resorbable prosthesis | – | –patients who have received a biosynthetic resorbable prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - emergency or planned surgery for an abdominal wall reconstruction, in the context of a contaminated surgery (mVHWG grade 3) at the CHU Strasbourg Hautepierre
Key inclusion criteria (4 listed)
- over 18 years old
- Patient who has consented to the use of her medical data for research purposes.
- emergency or planned surgery for an abdominal wall reconstruction, in the context of a contaminated surgery (mVHWG grade 3) at the CHU Strasbourg Hautepierre
- use of biological type (Cellis®, Xenmatrix®, Strattice®) or biosynthetic (Phasix®) parietal prostheses
Key exclusion criteria (2 listed)
- Refusal of the patient to participate in the study
- prosthesis placed prophylactically, subcutaneously, endoscopically, for bridge
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
Cost-effectiveness analysis
Time frame: 6 months after surgery
Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Derived from this study: PubMed 34116953Charleux-Muller D, Romain B, Boisson C, Velten M, Brigand C, Lejeune C. Cost-effectiveness analysis of resorbable biosynthetic mesh in contaminated ventral hernia repair. J Visc Surg. 2022 Aug;159(4):279-285. doi: 10.1016/j.jviscsurg.2021.06.001. Epub 2021 Jun 9.
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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, 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 2 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 20 Jul 2018. 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 Cécile BRIGAND, MD, PhD (33 3 88 12 72 26, Cecile.brigand@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness analysis (time frame: 6 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 NCT03590184, 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 20 Jul 2018.