PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results (BOOP)
This study has been completed.
Sponsor:
Göteborg University
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
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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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
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
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 May 16, 2013