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PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results

NCT ID: NCT00580177

Last Updated: 2007-12-24

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

PHASE4

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2005-07-31

Brief Summary

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Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.

Detailed Description

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Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair.

472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.

Conditions

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Hernia, Inguinal

Keywords

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Inguinal hernia Randomized controlled trial Surgery Complications Surgical mesh

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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L

The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch)

Group Type ACTIVE_COMPARATOR

Lichtenstein mesh

Intervention Type PROCEDURE

The different techniques are compared and evaluated according to primary and secondary objectives.

P

The well-konown PerFixPlug technique for inguinal hernia repair.

Group Type ACTIVE_COMPARATOR

PerFix Plug®

Intervention Type PROCEDURE

The different techniques are compared and evaluated according to primary and secondary objectives.

PHS

The well-known Prolene Hernia System method for inguinal hernia repair.

Group Type ACTIVE_COMPARATOR

Prolene® Hernia System

Intervention Type PROCEDURE

The different techniques are compared and evaluated according to primary and secondary objectives.

Interventions

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Lichtenstein mesh

The different techniques are compared and evaluated according to primary and secondary objectives.

Intervention Type PROCEDURE

PerFix Plug®

The different techniques are compared and evaluated according to primary and secondary objectives.

Intervention Type PROCEDURE

Prolene® Hernia System

The different techniques are compared and evaluated according to primary and secondary objectives.

Intervention Type PROCEDURE

Other Intervention Names

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Inguinal hernioplasty (surgical repair of inguinal hernia) Inguinal hernioplasty (surgical repair of inguinal hernia) Inguinal hernioplasty (surgical repair of inguinal hernia)

Eligibility Criteria

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Inclusion Criteria

* Age 30-75 years
* Men
* Primary inguinal hernia
* ASA I-III

Exclusion Criteria

* \> 75 years
* Females
* ASA IV
* Previous ipsi-lateral hernia surgery
* Drug or alchol abuse
* Severe illness
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Frolunda Specialist Hospital, Univeristy of Gothenburg

Principal Investigators

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Jan A Dalenbäck, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Frolunda Specialist Hospital, University of Gothenburg

Jan A Dalenbäck, Ass. Prof.

Role: STUDY_DIRECTOR

Frolunda Specialist Hospital, University of Gothenburg

Locations

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Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital

Gothenburg, Vastra Gotalandsregionen, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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FSS BOOP

Identifier Type: -

Identifier Source: org_study_id