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Polypropylene Meshes in Hernia Repair

Primary Purpose

Inguinal Hernias

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
two different meshes in the repair of inguinal hernias
Sponsored by
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernias focused on measuring Inguinal Hernia, contraction of two different meshes in the repair of inguinal hernias in men

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • São José HospitalRecruiting
  • Universidade do Extremo Sul CatarinenseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

two differents meshes

Arm Description

Heavy-weight versus low-weight polypropylene meshes

Outcomes

Primary Outcome Measures

contraction of two different meshes in the repair of inguinal hernias in men

Secondary Outcome Measures

Full Information

First Posted
March 18, 2010
Last Updated
March 18, 2010
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
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1. Study Identification

Unique Protocol Identification Number
NCT01090219
Brief Title
Polypropylene Meshes in Hernia Repair
Official Title
Morphofunctional Evaluations of Heavyweight and Ultralightweight Polypropylene Meshes in Men Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernias
Keywords
Inguinal Hernia, contraction of two different meshes in the repair of inguinal hernias in men

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
two differents meshes
Arm Type
Experimental
Arm Description
Heavy-weight versus low-weight polypropylene meshes
Intervention Type
Procedure
Intervention Name(s)
two different meshes in the repair of inguinal hernias
Intervention Description
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)
Primary Outcome Measure Information:
Title
contraction of two different meshes in the repair of inguinal hernias in men
Time Frame
digital radiography in post-surgical days: 1, 30, 60 and 90

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria I Rosa, Ph.D.
Phone
+5548 34339976
Email
mir@unesc.net
Facility Information:
Facility Name
São José Hospital
City
Criciúma
State/Province
Santa Catarina
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre C Silvestre, physician
Phone
+55 48 34312671
Facility Name
Universidade do Extremo Sul Catarinense
City
Criciúma
State/Province
SC
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria I Rosa, Ph.D.
Phone
+55 48 34339976
Email
mir@unesc.net
First Name & Middle Initial & Last Name & Degree
Alexandre C Silvestre, physician
First Name & Middle Initial & Last Name & Degree
Maria I Rosa, Ph.D.

12. IPD Sharing Statement

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Polypropylene Meshes in Hernia Repair

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