Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

Multicenter Descriptive Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery.

The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months.

The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia Repair

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Benoît ROMAIN, MD; Phone Number: 33 3 88 12 72 37; Email: benoit.romain@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67098
    • Recruiting
    • Service de chirurgie générale et digestive
    • Contact: Benoît ROMAIN, MD; Phone Number: 33 3 88 12 72 37; Email: benoit.romain@chru-strasbourg.fr
    • Principal Investigator: Benoît ROMAIN, MD
    • Sub-Investigator: Diane CHARLEUX-MULLER, MD
    • Sub-Investigator: Mahery RAHARIMANANTSOA, MD
    • Sub-Investigator: Vincent DUBUISSON, MD
    • Sub-Investigator: Pablo ORTEGA-DEBALLON, MD
    • Sub-Investigator: Yohann RENARD, MD
    • Sub-Investigator: Simone MANFREDELLI, MD
    • Sub-Investigator: Guillaume PASSOT, MD
    • Sub-Investigator: Cyril PERRENOT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Male or female adult patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,

Description

Inclusion Criteria:

• Male or female adult patient ( ≥18 years)
• Patient who has agreed to the use of his medical data for the purposes of this research,
• Patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
• Patient who benefited between May 2016 and September 2018 from a biosynthetic mesh

Exclusion Criteria:

• Patient who has not consented to the use of her medical data for the purposes of this research,
• Patients who have benefited from the placement of a Phasix® ST biosynthetic mesh in intraperitoneal or Phasix® in retro-muscular prophylaxis,
• Patient under safeguard of justice,
• Patient under guardianship or curatorship.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The main criterion will be clinical outcomes : complications and recurrence. It will be expressed in terms of complication according to the Clavien-Dindo classification	Files analysed retrospectily from May 1st, 2016 to December 31, 2021 will be examined

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Publications and helpful links

General Publications

• Charleux-Muller D, Hurel R, Fabacher T, Brigand C, Rohr S, Manfredelli S, Passot G, Ortega-Deballon P, Dubuisson V, Renard Y, Romain B. Slowly absorbable mesh in contaminated incisional hernia repair: results of a French multicenter study. Hernia. 2021 Aug;25(4):1051-1059. doi: 10.1007/s10029-020-02366-5. Epub 2021 Jan 25.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Descriptive study; Ventral hernia repair; Contaminated surgery; Biosynthetic absorbable mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 7398

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No