LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Ve... | NCT00788554

Studies
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

NCT00788554

Sponsor

Erasmus Medical Center

Status

Completed

Last Update Posted

Aug 19, 2011Estimated

Enrollment

660Actual

Phase

Phase 3

Conditions

Inguinal Hernia

Interventions

Lichtenstein procedure
TEP

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2000

Primary Completion Date

Mar 2004Actual

Completion Date

Mar 2011Actual

First Submitted Date

Nov 9, 2008

First Submission Date that Met QC Criteria

Nov 9, 2008

First Posted Date

Nov 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2011

Last Update Posted Date

Aug 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

660Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Procedure: Lichtenstein procedure
2	Active Comparator		Procedure: TEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lichtenstein procedure	Procedure	open surgical procedure for inguinal hernia correction	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hospital stay		7 days
postoperative pain		6 weeks
return to work		6 weeks
quality of life		5 years

Secondary Outcomes

Measure	Description	Time Frame
operating time		1 day
operating costs		1 week
complication

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J.F. Lange, professor	Erasmus Medical Center	Principal Investigator
J.J. Jeekel, professor	Erasmus Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus Medical Center		Rotterdam	South Holland	3015CE	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22430907	Derived	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.
20395851	Derived

ID	Term
D006552	Hernia, Inguinal
D006547	Hernia

ID	Term
D046449	Hernia, Abdominal
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms