Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia

Not Applicable

Completed

• Conditions: Hernia, Inguinal
• Interventions: Procedure: Mesh repair for primary inguinal hernia

• Registration Number: NCT01020058
• Lead Sponsor: Uppsala University Hospital

Brief Summary

The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2012-03
• Study Completion: 2012-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 384

Inclusion Criteria

• Unilateral inguinal hernia
• suitable for open mesh repair in local anesthesia as well as laparoscopic repair
• ASA score I-III
• informed consent

Exclusion Criteria

• ASA score IV (not suitable for TEP)
• bilateral hernias (laparoscopic repair preferable)
• recurrent hernia (primary repair affects preferable treatment)
• large scrotal hernias (not suitable for local anesthesia)
• earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lichtenstein in local anesthesia (LLA)	Mesh repair for primary inguinal hernia	Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein
TEP	Mesh repair for primary inguinal hernia	Patient receives a totally extraperitoneal laparoscopic repair

Primary Outcome Measures

Name	Time	Method
long-term post operative pain	6 wks, 1 year

Secondary Outcome Measures

Name	Time	Method
cost-effectiveness of the separate procedures	6wks, 1year

Trial Locations

Locations (2)

Enköping Hospital; 🇸🇪 Enkoping, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden