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

December 21, 2007 updated by: Göteborg University

Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

472

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Vastra Gotalandsregionen
      • Gothenburg, Vastra Gotalandsregionen, Sweden, SE-421 22
        • Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: L
The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch)
Procedure: Lichtenstein mesh
The different techniques are compared and evaluated according to primary and secondary objectives.
Other Names:
  • Inguinal hernioplasty (surgical repair of inguinal hernia)
ACTIVE_COMPARATOR: P
The well-konown PerFixPlug technique for inguinal hernia repair.
Procedure: PerFix Plug®
The different techniques are compared and evaluated according to primary and secondary objectives.
Other Names:
  • Inguinal hernioplasty (surgical repair of inguinal hernia)
ACTIVE_COMPARATOR: PHS
The well-known Prolene Hernia System method for inguinal hernia repair.
Procedure: Prolene® Hernia System
The different techniques are compared and evaluated according to primary and secondary objectives.
Other Names:
  • Inguinal hernioplasty (surgical repair of inguinal hernia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time until full functional recovery
Time Frame: 2 weeks, 3 months, 1 year, 3 years
2 weeks, 3 months, 1 year, 3 years
Operation time
Time Frame: Registered after completion of surgery
Registered after completion of surgery
Pain after operation measured on a VAS-scale and amount of consumed analgesics
Time Frame: Day 1-14, 3 months, 1 year, 3 years after surgery
Day 1-14, 3 months, 1 year, 3 years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication rate
Time Frame: 2 weeks, 3 months, 1 year, 3 years
2 weeks, 3 months, 1 year, 3 years
Aptness for beeing performed under local anaesthesia
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Jan A Dalenbäck, Ass. Prof., Frolunda Specialist Hospital, University of Gothenburg
  • Study Director: Jan A Dalenbäck, Ass. Prof., Frolunda Specialist Hospital, University of Gothenburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (ACTUAL)

July 1, 2005

Study Completion (ACTUAL)

July 1, 2005

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (ESTIMATE)

December 24, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2007

Last Update Submitted That Met QC Criteria

December 21, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSS BOOP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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