LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein
LEVEL
1 other identifier
interventional
660
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2000
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedAugust 19, 2011
August 1, 2011
3.6 years
November 9, 2008
August 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
hospital stay
7 days
postoperative pain
6 weeks
return to work
6 weeks
quality of life
5 years
Secondary Outcomes (6)
operating time
1 day
operating costs
1 week
complication
1 month
mortality
5 years
total costs
1 month
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- informed consent
- age \> 18 years
- inguinal hernia(primary, recurrence or bilateral)
- elective procedure
You may not qualify if:
- Scrotal hernia
- Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
- Participation in other trial
- Pregnancy
- Communicative or cognitive restrictions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus Medical Center
Rotterdam, South Holland, 3015CE, Netherlands
Related Publications (2)
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.
PMID: 22430907DERIVEDLangeveld 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.
PMID: 20395851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J.F. Lange, professor
Erasmus Medical Center
- PRINCIPAL INVESTIGATOR
J.J. Jeekel, professor
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. J.F. Lange
Study Record Dates
First Submitted
November 9, 2008
First Posted
November 11, 2008
Study Start
August 1, 2000
Primary Completion
March 1, 2004
Study Completion
March 1, 2011
Last Updated
August 19, 2011
Record last verified: 2011-08