Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis

NCT ID: NCT00323141

Last Updated: 2022-12-07

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-11

Study Completion Date

2017-08-31

Brief Summary

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To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.

Detailed Description

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Conditions

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Hernia, Umbilical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ventralex

Group Type ACTIVE_COMPARATOR

Ventralex versus Leight Weight Vypro II prothesis

Intervention Type DEVICE

Ventralex and Leight Weight Vypro II prothesis are compared.

Leight Weight Vypro II prothesis

Group Type ACTIVE_COMPARATOR

Ventralex versus Leight Weight Vypro II prothesis

Intervention Type DEVICE

Ventralex and Leight Weight Vypro II prothesis are compared.

Interventions

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Ventralex versus Leight Weight Vypro II prothesis

Ventralex and Leight Weight Vypro II prothesis are compared.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic hernia umbilicalis
* \> 18 years old

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2006/079

Identifier Type: -

Identifier Source: org_study_id

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