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

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. Identifier: NCT00788554
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : August 19, 2011
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Lichtenstein procedure Procedure: TEP Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
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.
Study Start Date : August 2000
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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

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

Secondary Outcome Measures :
  1. operating time [ Time Frame: 1 day ]
  2. operating costs [ Time Frame: 1 week ]
  3. complication [ Time Frame: 1 month ]
  4. mortality [ Time Frame: 5 years ]
  5. total costs [ Time Frame: 1 month ]
  6. recurrence [ Time Frame: 5 years ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00788554

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

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

Keywords provided by hasan eker, Erasmus Medical Center:

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