Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair

July 11, 2012 updated by: Raoul Droeser, University Hospital, Basel, Switzerland

Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair

Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."

Primary endpoints is recurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

594

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

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • University Hospital Basel

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

39 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).
  • provision of written informed consent,
  • symptomatic unilateral or bilateral inguinal hernia.

Exclusion Criteria:

  • presence of a femoral hernia,
  • history of hernia repair with mesh,
  • type I diabetes,
  • presence of local or diffuse infection (urine, skin, lung, sepsis),
  • immune deficiency,
  • severe medical problems contraindicating safe induction of general anaesthesia or elective surgery,
  • pregnancy,
  • malignant tumours and
  • life expectancy of less than 2 years

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
Other: Lichtenstein's Operation
Procedure: Lichtenstein's operation
Drug: Opiate
Postoperative pain therapy
Drug: Paracetamol
Postoperative pain therapy
Drug: non-steroidal anti-inflammatory drug
Postoperative pain therapy
Other: Mesh Plug Repair
Drug: Opiate
Postoperative pain therapy
Drug: Paracetamol
Postoperative pain therapy
Drug: non-steroidal anti-inflammatory drug
Postoperative pain therapy
Procedure: Mesh Plug Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 6 years
Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 6 years
Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)
6 years
Reoperation
Time Frame: 6 years
Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)
6 years
Sensitivity
Time Frame: 6 years
Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia
6 years

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Kantonsspital Olten
PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland
Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland

Investigators

  • Principal Investigator: Daniel M Frey, MD, GZO Wetzikon
  • Principal Investigator: Markus Zuber, Prof., Kantonsspital Olten
  • Principal Investigator: Jürg Metzger, Prof., Luzerner Kantonsspital
  • Principal Investigator: Rachel Rosenthal, Prof., University Hospital, Basel, Switzerland
  • Principal Investigator: Raoul Droeser, MD, University Hospital, Basel, Switzerland

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

September 1, 1999

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R59

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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