Clinical trial NCT03590184: Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventral Hernia
Keywords: Abdominal wall repair
Infection
Biologic mesh
Biosynthetic mesh
Cost-effectiveness
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Refusal of the patient to participate in the study
* prosthesis placed prophylactically, subcutaneously, endoscopically, for bridge

Primary outcomes:
measure: Cost-effectiveness analysis
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie générale et digestive
Study officials:
References:
citation: 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.