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

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Lichtenstein mesh
PerFix Plug®
Prolene® Hernia System
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Inguinal hernia, Randomized controlled trial, Surgery, Complications, Surgical mesh

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

L

P

PHS

Arm Description

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

The well-konown PerFixPlug technique for inguinal hernia repair.

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

Outcomes

Primary Outcome Measures

Time until full functional recovery
Operation time
Pain after operation measured on a VAS-scale and amount of consumed analgesics

Secondary Outcome Measures

Complication rate
Aptness for beeing performed under local anaesthesia

Full Information

First Posted
December 21, 2007
Last Updated
December 21, 2007
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT00580177
Brief Title
PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results
Acronym
BOOP
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Inguinal hernia, Randomized controlled trial, Surgery, Complications, Surgical mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L
Arm Type
Active Comparator
Arm Description
The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch)
Arm Title
P
Arm Type
Active Comparator
Arm Description
The well-konown PerFixPlug technique for inguinal hernia repair.
Arm Title
PHS
Arm Type
Active Comparator
Arm Description
The well-known Prolene Hernia System method for inguinal hernia repair.
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein mesh
Other Intervention Name(s)
Inguinal hernioplasty (surgical repair of inguinal hernia)
Intervention Description
The different techniques are compared and evaluated according to primary and secondary objectives.
Intervention Type
Procedure
Intervention Name(s)
PerFix Plug®
Other Intervention Name(s)
Inguinal hernioplasty (surgical repair of inguinal hernia)
Intervention Description
The different techniques are compared and evaluated according to primary and secondary objectives.
Intervention Type
Procedure
Intervention Name(s)
Prolene® Hernia System
Other Intervention Name(s)
Inguinal hernioplasty (surgical repair of inguinal hernia)
Intervention Description
The different techniques are compared and evaluated according to primary and secondary objectives.
Primary Outcome Measure Information:
Title
Time until full functional recovery
Time Frame
2 weeks, 3 months, 1 year, 3 years
Title
Operation time
Time Frame
Registered after completion of surgery
Title
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 Measure Information:
Title
Complication rate
Time Frame
2 weeks, 3 months, 1 year, 3 years
Title
Aptness for beeing performed under local anaesthesia
Time Frame
During surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Dalenbäck, Ass. Prof.
Organizational Affiliation
Frolunda Specialist Hospital, University of Gothenburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan A Dalenbäck, Ass. Prof.
Organizational Affiliation
Frolunda Specialist Hospital, University of Gothenburg
Official's Role
Study Director
Facility Information:
Facility Name
Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital
City
Gothenburg
State/Province
Vastra Gotalandsregionen
ZIP/Postal Code
SE-421 22
Country
Sweden

12. IPD Sharing Statement

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

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