Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

May 20, 2008 updated by: North Karelia Central Hospital

Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial

The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Finland
    • North Karelia
      • Joensuu, North Karelia, Finland, FI-80210
        • North Karelia Central Hospital - Clinic of Surgery

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • recurrent inguinal hernia
  • willing to participate

Exclusion Criteria:

  • unwilling to participate
  • bilateral hernia
  • preference towards either treatment arm

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: 1
Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia.
Procedure: Lichtenstein hernioplasty
Active Comparator: 2
Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia.
Procedure: Laparoscopic TEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
further recurrence
Time Frame: 3 weeks, 1 year, 2 years, 3 years
3 weeks, 1 year, 2 years, 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
chronic pain or discomfort
Time Frame: 3 weeks, 1 year, 2 years, 3 years
3 weeks, 1 year, 2 years, 3 years

Collaborators and Investigators

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

Sponsor

North Karelia Central Hospital

Collaborators

University of Kuopio Computing Center

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

January 1, 1997

Primary Completion (Actual)

February 1, 2002

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

May 22, 2008

Last Update Submitted That Met QC Criteria

May 20, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKCH-surg-001

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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