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Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

NCT ID: NCT04132986

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventral Hernia Repair

Keywords

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Ventral hernia repair Contaminated surgery Biosynthetic absorbable mesh Descriptive study

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de chirurgie générale et digestive

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Benoît ROMAIN, MD

Role: CONTACT

Phone: 33 3 88 12 72 37

Email: [email protected]

Facility Contacts

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Benoît ROMAIN, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33492554 (View on PubMed)

Other Identifiers

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7398

Identifier Type: -

Identifier Source: org_study_id