Polypropylene Meshes in Hernia Repair

NCT ID: NCT01090219

Last Updated: 2010-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-07-31

Brief Summary

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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

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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

Conditions

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Inguinal Hernias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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two differents meshes

Heavy-weight versus low-weight polypropylene meshes

Group Type EXPERIMENTAL

two different meshes in the repair of inguinal hernias

Intervention Type 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)

Interventions

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two different meshes in the repair of inguinal hernias

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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Universidade do Extremo Sul Catarinense

Locations

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São José Hospital

Criciúma, Santa Catarina, Brazil

Site Status RECRUITING

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Maria I Rosa, Ph.D.

Role: CONTACT

+5548 34339976

Facility Contacts

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Alexandre C Silvestre, physician

Role: primary

+55 48 34312671

Maria I Rosa, Ph.D.

Role: primary

+55 48 34339976

Other Identifiers

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0002.0.379.174.08

Identifier Type: -

Identifier Source: org_study_id

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