LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

Inguinal Hernia Clinical Trial

— LEVEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788554
• Other study ID #: LEVEL
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2008
• Last updated: August 18, 2011
• Start date: August 2000
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: March 2011
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Lichtenstein procedure
open surgical procedure for inguinal hernia correction
• TEP
Total Exta Peritoneal procedure for inguinal hernia correction

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital stay		7 days	No
Primary	postoperative pain		6 weeks	No
Primary	return to work		6 weeks	No
Primary	quality of life		5 years	No
Secondary	operating time		1 day	No
Secondary	operating costs		1 week	No
Secondary	complication		1 month	Yes
Secondary	mortality		5 years	Yes
Secondary	total costs		1 month	No
Secondary	recurrence		5 years	No