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Parietex Progrip Study

NCT ID: NCT00827944

Last Updated: 2016-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

603 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-10-31

Brief Summary

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The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.

Detailed Description

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* Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
* Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures.
* Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study.
* 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.

Conditions

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Hernia, Inguinal

Keywords

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Uncomplicated primary inguinal hernias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Parietex ProGrip

Group Type ACTIVE_COMPARATOR

Parietex Progrip

Intervention Type DEVICE

Surgical technique:

Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.

2

Low weight polypropylene mesh

Group Type ACTIVE_COMPARATOR

Low weight polypropylene mesh

Intervention Type DEVICE

Surgical technique:

Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Interventions

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Parietex Progrip

Surgical technique:

Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.

Intervention Type DEVICE

Low weight polypropylene mesh

Surgical technique:

Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All male patients at participating centers with a primary, uncomplicated inguinal hernia.
* Collar of the defect ≤ 4 cm
* Signed informed consent

Exclusion Criteria

* 30 years ≥ Age ≥ 75 years
* Emergency procedure
* Inclusion in other trials
* Bilateral inguinal hernia
* Recurrence
Minimum Eligible Age

31 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

Klinikum Bremen-Mitte

Bremen, , Germany

Site Status

Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik

Fulda, , Germany

Site Status

Catharina-ziekenhuis

Eindhoven, , Netherlands

Site Status

Medical Center Linköping

Linköping, , Sweden

Site Status

Centre of clinical research

Västeras-, , Sweden

Site Status

Western Infirmary

Glasgow, , United Kingdom

Site Status

Imperial College London / Faculty of Medecine

London, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Countries

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Belgium Germany Netherlands Sweden United Kingdom

References

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Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.

Reference Type DERIVED
PMID: 25146918 (View on PubMed)

Other Identifiers

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SC 0607/1

Identifier Type: -

Identifier Source: org_study_id