Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with a biological prosthesis

patients who have received a biological prosthesis

No interventions assigned to this group

patients with a biosynthetic resorbable prosthesis

patients who have received a biosynthetic resorbable prosthesis

No interventions assigned to this group

Eligibility Criteria

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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