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

N/ACompletedNCT01020058

Uppsala University Hospital384 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

384

Conditions

Hernia, Inguinal

Interventions

Mesh repair for primary inguinal hernia

Eligibility

Sex: MALEMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (2)

Enköping Hospital

Enköping, Sweden

Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

long-term post operative pain

Time frame: 6 wks, 1 year

Secondary Outcomes

cost-effectiveness of the separate procedures

Time frame: 6wks, 1year