LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

Phase 3

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Lichtenstein procedure; Procedure: TEP

• Registration Number: NCT00788554
• Lead Sponsor: Erasmus Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2004-03
• Study First Submitted: 2008-11-09
• Study First Submitted QC: 2008-11-09
• Study First Posted: 2008-11-11
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-18
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lichtenstein procedure	-
2	TEP	-

Primary Outcome Measures

Name	Time	Method
hospital stay	7 days
postoperative pain	6 weeks
return to work	6 weeks
quality of life	5 years

Secondary Outcome Measures

Name	Time	Method
total costs	1 month
recurrence	5 years
operating time	1 day
operating costs	1 week
complication	1 month
mortality	5 years

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid Holland, Netherlands