Informations générales (source: ClinicalTrials.gov)

NCT04132986 Statut inconnu
Multicenter Descriptive Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair
Observational
  • Hernie
  • Hernie ventrale
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
avril 2019
juin 2023
29 juin 2024
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.

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Service de chirurgie générale et digestive - 67098 - Strasbourg - France Benoît ROMAIN, MD En recrutement Contact (sur clinicalTrials)

Critères

Femme
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



- 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.