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

Hernia, Inguinal Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580177
• Other study ID #: FSS BOOP
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: January 2000
• Est. completion date: July 2005

Study information

• Verified date: December 2007
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Lichtenstein mesh
The different techniques are compared and evaluated according to primary and secondary objectives.
• PerFix Plug®
The different techniques are compared and evaluated according to primary and secondary objectives.
• Prolene® Hernia System
The different techniques are compared and evaluated according to primary and secondary objectives.

Locations

Country	Name	City	State
Sweden	Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital	Gothenburg	Vastra Gotalandsregionen

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until full functional recovery		2 weeks, 3 months, 1 year, 3 years	No
Primary	Operation time		Registered after completion of surgery	No
Primary	Pain after operation measured on a VAS-scale and amount of consumed analgesics		Day 1-14, 3 months, 1 year, 3 years after surgery	No
Secondary	Complication rate		2 weeks, 3 months, 1 year, 3 years	Yes
Secondary	Aptness for beeing performed under local anaesthesia		During surgery	Yes