Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device

NCT ID: NCT01622712

Last Updated: 2022-12-29

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

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-01

Study Completion Date

2014-09-02

Brief Summary

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The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.

Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.

Detailed Description

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Conditions

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Unilateral Inguinal Hernia

Keywords

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inguinal 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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Unilateral inguinal hernia

A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.

Group Type EXPERIMENTAL

Rebound HRD Mesh

Intervention Type DEVICE

Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.

Interventions

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Rebound HRD Mesh

Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* elective repair for a primary unilateral inguinal hernia OR
* elective repair for a recurrent unilateral inguinal hernia after non-mesh repair
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medri

UNKNOWN

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, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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ASZ Aalst

Aalst, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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2011/823

Identifier Type: -

Identifier Source: org_study_id