LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00788554
First received: November 9, 2008
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Inguinal Hernia
Procedure: Lichtenstein procedure
Procedure: TEP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • postoperative pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • return to work [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • operating time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • operating costs [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • total costs [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: August 2000
Study Completion Date: March 2011
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Lichtenstein procedure
open surgical procedure for inguinal hernia correction
Active Comparator: 2 Procedure: TEP
Total Exta Peritoneal procedure for inguinal hernia correction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788554

Locations
Netherlands
Erasmus Medical Center
Rotterdam, Zuid Holland, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: J.F. Lange, professor Erasmus Medical Center
Principal Investigator: J.J. Jeekel, professor Erasmus Medical Center
  More Information

No publications provided by Erasmus Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: hasan eker, Prof. Dr. J.F. Lange, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00788554     History of Changes
Other Study ID Numbers: LEVEL
Study First Received: November 9, 2008
Last Updated: August 18, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
groin
inguinal
hernia
lichtenstein
TEP

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014