A Multi-site Trial Comparing Lichtensteins Operation and... | NCT00184483

Studies
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair

NCT00184483

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Sep 10, 2020Actual

Enrollment

405Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

Lichtenstein's operation
Prolene Hernia System

Countries

Norway

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

Sep 2020

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

Oct 2001

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 15, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 16, 2005Estimated

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

Sep 9, 2020

Last Update Posted Date

Sep 10, 2020Actual

Name	Class
Sorlandet Hospital HF	OTHER_GOV
Voss Sykehus	UNKNOWN
Haraldsplass Deaconess Hospital	OTHER
Sykehuset Ostfold

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain 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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

405Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lichtenstein's operation	Experimental	Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia	Procedure: Lichtenstein's operation
Prolene Hernia System	Active Comparator	Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia	Procedure: Prolene Hernia System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lichtenstein's operation	Procedure	Lichtenstein's operation to repair primary unilateral inguinal hernia	Lichtenstein's operation

Measure	Description	Time Frame
pain postoperative		3 years

Measure	Description	Time Frame
Recurrences after groin hernia repair		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary unilateral groin hernia in adult

Exclusion Criteria:

recurrence warfarin treatment bilateral groin hernia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helge E Myrvold, MD PhD	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olavs Hospital		Trondheim		7006	Norway

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D010149	Pain, Postoperative
D012008	Recurrence

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided