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

January 5, 2016 updated by: Ursula Dahlstrand, Uppsala University Hospital

Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Enkoping, Sweden, 75436
        • Enköping Hospital
      • Uppsala, Sweden, 751 85
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lichtenstein in local anesthesia (LLA)
Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein
Procedure: 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
Other Names:
  • TEP
  • Lichtenstein (LLA)
ACTIVE_COMPARATOR: TEP
Patient receives a totally extraperitoneal laparoscopic repair
Procedure: 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
Other Names:
  • TEP
  • Lichtenstein (LLA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
long-term post operative pain
Time Frame: 6 wks, 1 year
6 wks, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
cost-effectiveness of the separate procedures
Time Frame: 6wks, 1year
6wks, 1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Collaborators

Uppsala County Council, Sweden

Investigators

  • Study Director: Staffan Wollert, MD, PhD, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (ESTIMATE)

November 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004:M-360

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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