LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

hasan eker, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT00788554

First received: November 9, 2008

Last updated: August 18, 2011

Last verified: August 2011

History of Changes

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Endoscopy Hernia

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
postoperative pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
return to work [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

operating time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
operating costs [ Time Frame: 1 week ] [ Designated as safety issue: No ]
complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
total costs [ Time Frame: 1 month ] [ Designated as safety issue: No ]
recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Erasmus Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	hasan eker, Prof. Dr. J.F. Lange, Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00788554 History of Changes
Other Study ID Numbers:	LEVEL
Study First Received:	November 9, 2008
Last Updated:	August 18, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:

groin
inguinal
hernia
lichtenstein
TEP

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 23, 2013

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