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LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00788554
Acronym
LEVEL
Enrollment
660
Registered
2008-11-11
Start date
2000-08-31
Completion date
2011-03-31
Last updated
2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

groin, inguinal, hernia, lichtenstein, TEP

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

Interventions

PROCEDURELichtenstein procedure

open surgical procedure for inguinal hernia correction

PROCEDURETEP

Total Exta Peritoneal procedure for inguinal hernia correction

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
hospital stay7 days
postoperative pain6 weeks
return to work6 weeks
quality of life5 years

Secondary

MeasureTime frame
mortality5 years
recurrence5 years
total costs1 month
operating time1 day
operating costs1 week
complication1 month

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026