LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein (LEVEL)

August 18, 2011 updated by: hasan eker, Erasmus Medical Center

LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.

The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Phase 3

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

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3015CE
        • Erasmus Medical Center

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:

  • informed consent
  • age > 18 years
  • inguinal hernia(primary, recurrence or bilateral)
  • elective procedure

Exclusion Criteria:

  • Scrotal hernia
  • Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
  • Participation in other trial
  • Pregnancy
  • Communicative or cognitive restrictions

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: 1
Procedure: Lichtenstein procedure
open surgical procedure for inguinal hernia correction
ACTIVE_COMPARATOR: 2
Procedure: TEP
Total Exta Peritoneal procedure for inguinal hernia correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hospital stay
Time Frame: 7 days
7 days
postoperative pain
Time Frame: 6 weeks
6 weeks
return to work
Time Frame: 6 weeks
6 weeks
quality of life
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
operating time
Time Frame: 1 day
1 day
operating costs
Time Frame: 1 week
1 week
complication
Time Frame: 1 month
1 month
mortality
Time Frame: 5 years
5 years
total costs
Time Frame: 1 month
1 month
recurrence
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: J.J. Jeekel, professor, Erasmus Medical 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

August 1, 2000

Primary Completion (ACTUAL)

March 1, 2004

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

November 9, 2008

First Submitted That Met QC Criteria

November 9, 2008

First Posted (ESTIMATE)

November 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEVEL

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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