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Polypropylene Meshes in Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
ClinicalTrials.gov Identifier:
NCT01090219
First received: March 18, 2010
Last updated: NA
Last verified: February 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 18, 2010
Last Updated: March 18, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 23, 2013