Polypropylene Meshes in Hernia Repair | NCT01090219

Studies
Polypropylene Meshes in Hernia Repair

NCT01090219

Sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Status

Unknown status

Last Update Posted

Mar 19, 2010Estimated

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Inguinal Hernias

Interventions

two different meshes in the repair of inguinal hernias

Countries

Brazil

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

Feb 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

Mar 18, 2010

First Submission Date that Met QC Criteria

Mar 18, 2010

First Posted Date

Mar 19, 2010Estimated

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

Mar 18, 2010

Last Update Posted Date

Mar 19, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeOTHER

Collaborators

Not provided

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 was to analyze the shrinkage of two different screens in the repair of inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly. A Lichtenstein tension-free hernia repair was accomplished by emplacing heavy weight versus ultralight weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200).

Detailed Description

eligibility criteria : Elective Surgery, men with unilateral inguinal hernia, 20 - 50 years Exclusion criteria: BMI> 30, recurrent inguinal hernia, strangulated inguinal hernia, anesthetic risk ASA III and IV, Diabetics, COPD, benign prostatic hypertrophy,cancer disease

outcome: Percentage of contraction of the different meshes by digital radiography in post-surgical days: 1, 30, 60 and 90

Independent variables: age, BMI, smoking, ethnicity, profession

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

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
two differents meshes	Experimental	Heavy-weight versus low-weight polypropylene meshes	Procedure: two different meshes in the repair of inguinal hernias

Interventions

Name	Type	Description	Arm Group Labels	Other Names
two different meshes in the repair of inguinal hernias	Procedure	A Lichtenstein tension-free hernia repair was accomplished by emplacing Heavy-weight versus low-weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
contraction of two different meshes in the repair of inguinal hernias in men		digital radiography in post-surgical days: 1, 30, 60 and 90

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective Surgery
Men with unilateral inguinal hernia
Age 20 - 50 years

Exclusion Criteria:

BMI> 30
Recurrent inguinal hernia
Strangulated inguinal hernia
Anesthetic risk ASA III and IV
Diabetics
COPD
Benign prostatic hypertrophy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria I Rosa, Ph.D.	Contact	+5548 34339976		mir@unesc.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São José Hospital	Recruiting	Criciúma	Santa Catarina		Brazil

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

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Browse Branches

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