Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

NCT04132986 | Unknown

• 1 other identifier: 7398
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia Repair

Keywords

Ventral hernia repair; Contaminated surgery; Biosynthetic absorbable mesh; Descriptive study

Outcome Measures

Primary Outcomes (1)

• 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

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de chirurgie générale et digestive

Strasbourg, 67098, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 33492554 DERIVED

Central Study Contacts

Benoît ROMAIN, MD

CONTACT

33 3 88 12 72 37; benoit.romain@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 21, 2019
• Study Start: April 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-11

Locations

FR (1)