Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

NCT ID: NCT00572962

Last Updated: 2022-12-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-08-31

Brief Summary

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1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
2. Laparoscopic surgery

* at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
* with or without anchoring transparietal sutures or double crown technique

Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Group Type EXPERIMENTAL

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Intervention Type PROCEDURE

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Interventions

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use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* written informed consent from the patient or his/her legal representative
* ventral hernia requiring elective surgical repair

Exclusion Criteria

* no written informed consent
* 'hostile' abdomen; open abdomen treatment
* contraindication to pneumoperitoneum
* emergency surgery (incarcerated hernia)
* parastomal hernia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederik Berrevoet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Berrevoet F, Tollens T, Berwouts L, Bertrand C, Muysoms F, De Gols J, Meir E, De Backer A. A belgian multicenter prospective observational cohort study shows safe and efficient use of a composite mesh with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair. Acta Chir Belg. 2014 Jul-Aug;114(4):233-8.

Reference Type DERIVED
PMID: 26021417 (View on PubMed)

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2007/268

Identifier Type: -

Identifier Source: org_study_id