LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

Erasmus University

Status and phase: Completed; Phase 3

Conditions: Inguinal Hernia

Treatments: Procedure: Lichtenstein procedure; Procedure: TEP

Study type: Interventional

Funder types: Other

Identifiers

NCT00788554

LEVEL

Details and patient eligibility

About

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

Enrollment: 660 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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660 participants in 2 patient groups

1

Active Comparator group

Treatment:

Procedure: Lichtenstein procedure

2

Active Comparator group

Treatment:

Procedure: TEP