LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

NCT ID: NCT00788554

Last Updated: 2011-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Lichtenstein procedure

Intervention Type PROCEDURE

open surgical procedure for inguinal hernia correction

2

Group Type ACTIVE_COMPARATOR

TEP

Intervention Type PROCEDURE

Total Exta Peritoneal procedure for inguinal hernia correction

Interventions

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Lichtenstein procedure

open surgical procedure for inguinal hernia correction

Intervention Type PROCEDURE

TEP

Total Exta Peritoneal procedure for inguinal hernia correction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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hasan eker

Prof. Dr. J.F. Lange

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J.F. Lange, professor

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

J.J. Jeekel, professor

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 22430907 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20395851 (View on PubMed)

Other Identifiers

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LEVEL

Identifier Type: -

Identifier Source: org_study_id

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