Randomized Multicentre Study Comparing TEP With Lichtenst... | NCT00568269

Studies
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

NCT00568269

Sponsor

Uppsala University Hospital

Status

Completed

Last Update Posted

Dec 6, 2007Estimated

Enrollment

1,513Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

Open repair
Laparoscopic repair

Countries

Sweden

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

ID	Type	Description	Link
Ups 144-96

Status Module

Record Verification Date

Dec 2007

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

Nov 1996

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Dec 5, 2007

First Submission Date that Met QC Criteria

Dec 5, 2007

First Posted Date

Dec 6, 2007Estimated

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

Dec 5, 2007

Last Update Posted Date

Dec 6, 2007Estimated

Name	Class
Stig and Ragna Gorthon Foundation	UNKNOWN
Tyco Healthcare Group	INDUSTRY

Description Module

Brief Summary

The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.

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

1,513Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lichtenstein	Active Comparator		Procedure: Open repair
TEP	Experimental		Procedure: Laparoscopic repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open repair	Procedure	Open repair is according to the Lichtenstein technique	Lichtenstein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence rate		5 years

Secondary Outcomes

Measure	Description	Time Frame
Operative complications, postoperative recovery and chronic pain at 5 years.		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
Age 30-70 years referred to hospital with a primary inguinal hernia.

Exclusion Criteria:

Recurrent hernia
Scrotal or bilateral hernia
Previous lower abdominal surgery
Unable to participate in follow up
ASA more than 3
Bleeding diathesis.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 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
Arne S Eklund, MD	Centre for Clinical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Clinical Research, Central hospital, entrance 29		Västerås		721 89	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16862612	Result	Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
20186889	Derived

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