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Polypropylene Meshes in Hernia Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090219
First Posted: March 19, 2010
Last Update Posted: March 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
  Purpose
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).

Condition Intervention
Inguinal Hernias Procedure: two different meshes in the repair of inguinal hernias

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Morphofunctional Evaluations of Heavyweight and Ultralightweight Polypropylene Meshes in Men Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: February 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090219


Contacts
Contact: Maria I Rosa, Ph.D. +5548 34339976 mir@unesc.net

Locations
Brazil
São José Hospital Recruiting
Criciúma, Santa Catarina, Brazil
Contact: Alexandre C Silvestre, physician    +55 48 34312671      
Universidade do Extremo Sul Catarinense Recruiting
Criciúma, SC, Brazil
Contact: Maria I Rosa, Ph.D.    +55 48 34339976    mir@unesc.net   
Sub-Investigator: Alexandre C Silvestre, physician         
Principal Investigator: Maria I Rosa, Ph.D.         
Sponsors and Collaborators
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
  More Information

Responsible Party: Morphofunctional evaluations of heavyweight and ultralightweight polypropylene meshes in men inguinal hernia repair, Universidade do Extremo Sul Catarinense
ClinicalTrials.gov Identifier: NCT01090219     History of Changes
Other Study ID Numbers: 0002.0.379.174.08
First Submitted: March 18, 2010
First Posted: March 19, 2010
Last Update Posted: March 19, 2010
Last Verified: February 2008

Keywords provided by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude:
Inguinal Hernia
contraction of two different meshes in the repair of inguinal hernias in men

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal