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LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein (LEVEL)

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Lichtenstein procedure
TEP
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring groin, inguinal, hernia, lichtenstein, TEP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

hospital stay
postoperative pain
return to work
quality of life

Secondary Outcome Measures

operating time
operating costs
complication
mortality
total costs
recurrence

Full Information

First Posted
November 9, 2008
Last Updated
August 18, 2011
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00788554
Brief Title
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein
Acronym
LEVEL
Official Title
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
groin, inguinal, hernia, lichtenstein, TEP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein procedure
Intervention Description
open surgical procedure for inguinal hernia correction
Intervention Type
Procedure
Intervention Name(s)
TEP
Intervention Description
Total Exta Peritoneal procedure for inguinal hernia correction
Primary Outcome Measure Information:
Title
hospital stay
Time Frame
7 days
Title
postoperative pain
Time Frame
6 weeks
Title
return to work
Time Frame
6 weeks
Title
quality of life
Time Frame
5 years
Secondary Outcome Measure Information:
Title
operating time
Time Frame
1 day
Title
operating costs
Time Frame
1 week
Title
complication
Time Frame
1 month
Title
mortality
Time Frame
5 years
Title
total costs
Time Frame
1 month
Title
recurrence
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.F. Lange, professor
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J.J. Jeekel, professor
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015CE
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22430907
Citation
Eker HH, Langeveld HR, Klitsie PJ, van't Riet M, Stassen LP, Weidema WF, Steyerberg EW, Lange JF, Bonjer HJ, Jeekel J. Randomized clinical trial of total extraperitoneal inguinal hernioplasty vs Lichtenstein repair: a long-term follow-up study. Arch Surg. 2012 Mar;147(3):256-60. doi: 10.1001/archsurg.2011.2023.
Results Reference
derived
PubMed Identifier
20395851
Citation
Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.
Results Reference
derived

Learn more about this trial

LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

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