Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

December 5, 2007 updated by: Uppsala University Hospital
The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1513

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
      • Västerås, Sweden, 721 89
        • Centre for Clinical Research, Central hospital, entrance 29

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Age 30-70 years referred to hospital with a primary inguinal hernia.

Exclusion Criteria:

  • Recurrent hernia
  • Scrotal or bilateral hernia
  • Previous lower abdominal surgery
  • Unable to participate in follow up
  • ASA more than 3
  • Bleeding diathesis.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lichtenstein
Procedure: Open repair
Open repair is according to the Lichtenstein technique
Experimental: TEP
Procedure: Laparoscopic repair
The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Operative complications, postoperative recovery and chronic pain at 5 years.
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Uppsala University Hospital

Collaborators

Tyco Healthcare Group
Stig and Ragna Gorthon Foundation

Investigators

  • Principal Investigator: Arne S Eklund, MD, Centre for Clinical Research

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

November 1, 1996

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 5, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

December 6, 2007

Last Update Submitted That Met QC Criteria

December 5, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMIL II
  • Ups 144-96

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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