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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788554
First Posted: November 11, 2008
Last Update Posted: August 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
  Purpose
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

Condition Intervention Phase
Inguinal Hernia Procedure: Lichtenstein procedure Procedure: TEP Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by hasan eker, Erasmus Medical Center:

Primary Outcome Measures:
  • hospital stay [ Time Frame: 7 days ]
  • postoperative pain [ Time Frame: 6 weeks ]
  • return to work [ Time Frame: 6 weeks ]
  • quality of life [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • operating time [ Time Frame: 1 day ]
  • operating costs [ Time Frame: 1 week ]
  • complication [ Time Frame: 1 month ]
  • mortality [ Time Frame: 5 years ]
  • total costs [ Time Frame: 1 month ]
  • recurrence [ Time Frame: 5 years ]

Enrollment: 660
Study Start Date: August 2000
Study Completion Date: March 2011
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788554


Locations
Netherlands
Erasmus Medical Center
Rotterdam, Zuid Holland, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: J.F. Lange, professor Erasmus Medical Center
Principal Investigator: J.J. Jeekel, professor Erasmus Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: hasan eker, Prof. Dr. J.F. Lange, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00788554     History of Changes
Other Study ID Numbers: LEVEL
First Submitted: November 9, 2008
First Posted: November 11, 2008
Last Update Posted: August 19, 2011
Last Verified: August 2011

Keywords provided by hasan eker, Erasmus Medical Center:
groin
inguinal
hernia
lichtenstein
TEP

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal