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

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00580177
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
  • Operation time [ Time Frame: Registered after completion of surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   30 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on August 27, 2014