NCT00788554CompletedPhase 3
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Erasmus Medical Center
- Enrollment
- 660
- Locations
- 1
- Primary Endpoint
- hospital stay
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
1
Active Comparator
Intervention: Lichtenstein procedure (Procedure)
2
Active Comparator
Intervention: TEP (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- recurrence(5 years)
- total costs(1 month)
- operating time(1 day)
- operating costs(1 week)
- complication(1 month)
- mortality(5 years)
Investigators
hasan eker
Prof. Dr. J.F. Lange
Erasmus Medical Center
Study Sites (1)
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