Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

Ventral Hernia Repair Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132986
• Other study ID #: 7398
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2021
• Source: University Hospital, Strasbourg, France
• Contact: Benoît ROMAIN, MD
• Phone: 33 3 88 12 72 37
• Email: benoit.romain[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia Repair

Locations

Country	Name	City	State
France	Service de chirurgie générale et digestive	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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