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Clinical Trials/NCT00788554
NCT00788554
Completed
Phase 3

LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.

Erasmus Medical Center1 site in 1 country660 target enrollmentAugust 2000
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ConditionsInguinal Hernia

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Erasmus Medical Center
Enrollment
660
Locations
1
Primary Endpoint
hospital stay
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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

Registry
clinicaltrials.gov
Start Date
August 2000
End Date
March 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

hasan eker

Prof. Dr. J.F. Lange

Erasmus Medical Center

Eligibility 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

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

  • total costs(1 month)
  • recurrence(5 years)
  • operating time(1 day)
  • operating costs(1 week)
  • complication(1 month)
  • mortality(5 years)

Study Sites (1)

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