Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: no suture; Procedure: suture

• Registration Number: NCT00815698
• Lead Sponsor: Jacob Rosenberg

Brief Summary

The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.

Detailed Description

Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-29
• Study First Posted: 2008-12-30
• Primary Completion: 2011-04
• Study Completion: 2011-09
• Results First Submitted: 2015-03-18
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Results First Posted: 2016-03-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 334

Inclusion Criteria

• Healthy males 18-80 years
• Primary inguinal unilateral hernia

Exclusion Criteria

• Recurrent hernia
• Bilateral, scrotal or femoral hernia
• BMI above 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no suture	no suture	self-adhesive mesh, i.e. no suture for mesh fixation
Suture	suture	Suture for mesh fixation

Primary Outcome Measures

Name	Time	Method
Pain, Numbness and Discomfort in the Groin	12 months after surgery	The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.

Secondary Outcome Measures

Name	Time	Method
Recurrence	12 months after surgery	recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.

Trial Locations

Locations (5)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhaven, Denmark

Gentofte Hospital; 🇩🇰 Gentofte, Hellerup, Denmark

Nyborg Hospital; 🇩🇰 Nyborg, Svendborg, Denmark

Frederikshavn Hospital; 🇩🇰 Frederikshavn, Denmark

Randers Hospital; 🇩🇰 Randers, Denmark