Polypropylene Meshes in Hernia Repair

March 18, 2010 updated by: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Morphofunctional Evaluations of Heavyweight and Ultralightweight Polypropylene Meshes in Men Inguinal Hernia Repair

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SC
      • Criciúma, SC, Brazil
        • Recruiting
        • Universidade do Extremo Sul Catarinense
        • Contact:
          • Maria I Rosa, Ph.D.
          • Phone Number: +55 48 34339976
          • Email: mir@unesc.net
        • Sub-Investigator:
          • Alexandre C Silvestre, physician
        • Principal Investigator:
          • Maria I Rosa, Ph.D.
    • Santa Catarina
      • Criciúma, Santa Catarina, Brazil
        • Recruiting
        • São José Hospital
        • Contact:
          • Alexandre C Silvestre, physician
          • Phone Number: +55 48 34312671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: two differents meshes
Heavy-weight versus low-weight polypropylene meshes
Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
digital radiography in post-surgical days: 1, 30, 60 and 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 19, 2010

Study Record Updates

Last Update Posted (Estimate)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002.0.379.174.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inguinal Hernias

Clinical Trials on two different meshes in the repair of inguinal hernias

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe