Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses

July 18, 2018 updated by: University Hospital, Strasbourg, France

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.

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
        • Recruiting
        • Service de chirurgie générale et digestive
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cécile BRIGAND, MD, PhD
        • Sub-Investigator:
          • Diane Muller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness analysis
Time Frame: 6 months after surgery
Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7126

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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