Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04132986

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ventral Hernia Repair

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.