Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses

NCT03590184 | Unknown

• 1 other identifier: 7126
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

Abdominal wall repair; Infection; Biologic mesh; Biosynthetic mesh; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Cost-effectiveness analysis

  Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses

  6 months after surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Chirurgie générale et digestive

Strasbourg, 67098, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 34116953 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Infections

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cécile BRIGAND, MD, PhD

CONTACT

33 3 88 12 72 26; Cecile.brigand@chru-strasbourg.fr

Diane MULLER

CONTACT

33 3 88 12 72 26; diane.muller@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 18, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

FR (1)