LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein
NCT ID: NCT00788554
Last Updated: 2011-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
660 participants
INTERVENTIONAL
2000-08-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Lichtenstein procedure
open surgical procedure for inguinal hernia correction
2
TEP
Total Exta Peritoneal procedure for inguinal hernia correction
Interventions
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Lichtenstein procedure
open surgical procedure for inguinal hernia correction
TEP
Total Exta Peritoneal procedure for inguinal hernia correction
Eligibility Criteria
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Inclusion Criteria
* age \> 18 years
* inguinal hernia(primary, recurrence or bilateral)
* elective procedure
Exclusion Criteria
* Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
* Participation in other trial
* Pregnancy
* Communicative or cognitive restrictions
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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hasan eker
Prof. Dr. J.F. Lange
Principal Investigators
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J.F. Lange, professor
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
J.J. Jeekel, professor
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Countries
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References
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Eker HH, Langeveld HR, Klitsie PJ, van't Riet M, Stassen LP, Weidema WF, Steyerberg EW, Lange JF, Bonjer HJ, Jeekel J. Randomized clinical trial of total extraperitoneal inguinal hernioplasty vs Lichtenstein repair: a long-term follow-up study. Arch Surg. 2012 Mar;147(3):256-60. doi: 10.1001/archsurg.2011.2023.
Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.
Other Identifiers
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LEVEL
Identifier Type: -
Identifier Source: org_study_id
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