Randomized Controlled Study Comparing Three Different Tec... | NCT01699971

Studies
Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

NCT01699971

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Oct 4, 2012Estimated

Enrollment

160Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

Hernia repair
Hernia repair
Hernia 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

Status Module

Record Verification Date

Sep 2012

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 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2012Actual

First Submitted Date

Oct 1, 2012

First Submission Date that Met QC Criteria

Oct 3, 2012

First Posted Date

Oct 4, 2012Estimated

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

Oct 3, 2012

Last Update Posted Date

Oct 4, 2012Estimated

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

The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups

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

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lichtenstein	Active Comparator	Hernia repair with lichtenstein propylene mesh	Procedure: Hernia repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hernia repair	Procedure	Hernia repair admodum Lichtenstein with polypropylene mesh	Lichtenstein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperatively pain	Visual analog scale (VAS)	Postoperative 36 month

Secondary Outcomes

Measure	Description	Time Frame
Quality of life	SF36	36 month postoperative
frequency of recurrencies	check patients journal	postopertive 36 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-75 years
unilateral primary hernia
open surgery

Exclusion Criteria:

Recurrent Hernia
Bilateral Hernia
laparoscopic surgery
Female

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
Anders Thorell, Assoc Prof	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ersta Hospital		Stockholm		116 91	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

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

Intervention Browse Module

MeSH Terms

ID	Term
D059685	Herniorrhaphy

Ancestor Terms

ID	Term
D019651	Plastic Surgery Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided