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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Göteborg University

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Göteborg University

Dates:
Date Received: December 21, 2007
Date Started: January 2000
Date Completion:
Last Updated: December 21, 2007
Last Verified: December 2007