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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580177
First Posted: December 24, 2007
Last Update Posted: December 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Göteborg University
  Purpose
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.

Condition Intervention Phase
Hernia, Inguinal Procedure: Lichtenstein mesh Procedure: PerFix Plug® Procedure: Prolene® Hernia System Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Time until full functional recovery [ Time Frame: 2 weeks, 3 months, 1 year, 3 years ]
  • Operation time [ Time Frame: 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 ]

Secondary Outcome Measures:
  • Complication rate [ Time Frame: 2 weeks, 3 months, 1 year, 3 years ]
  • Aptness for beeing performed under local anaesthesia [ Time Frame: During surgery ]

Enrollment: 472
Study Start Date: January 2000
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Inguinal hernioplasty (surgical repair of inguinal hernia)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580177


Locations
Sweden
Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital
Gothenburg, Vastra Gotalandsregionen, Sweden, SE-421 22
Sponsors and Collaborators
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
  More Information

Responsible Party: Jan Dalenbäck Associate Professor, Frolunda Specialist Hospital, Univeristy of Gothenburg
ClinicalTrials.gov Identifier: NCT00580177     History of Changes
Other Study ID Numbers: FSS BOOP
First Submitted: December 21, 2007
First Posted: December 24, 2007
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Göteborg University:
Inguinal hernia
Randomized controlled trial
Surgery
Complications
Surgical mesh

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal


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