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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lichtenstein in local anesthesia (LLA)

Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein

Group Type ACTIVE_COMPARATOR

Mesh repair for primary inguinal hernia

Intervention Type PROCEDURE

Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh

TEP

Patient receives a totally extraperitoneal laparoscopic repair

Group Type ACTIVE_COMPARATOR

Mesh repair for primary inguinal hernia

Intervention Type PROCEDURE

Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh

Interventions

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Mesh repair for primary inguinal hernia

Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh

Intervention Type PROCEDURE

Other Intervention Names

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Lichtenstein (LLA) TEP

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No