Polypropylene Meshes in Hernia Repair

Inguinal Hernias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01090219
• Other study ID #: 0002.0.379.174.08
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2010
• Last updated: March 18, 2010
• Start date: February 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2008
• Source: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Contact: Maria I Rosa, Ph.D.
• Phone: +5548 34339976
• Email: mir[@]unesc.net
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernias

Intervention

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)

Locations

Country	Name	City	State
Brazil	São José Hospital	Criciúma	Santa Catarina
Brazil	Universidade do Extremo Sul Catarinense	Criciúma	SC

Sponsors (1)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contraction of two different meshes in the repair of inguinal hernias in men		digital radiography in post-surgical days: 1, 30, 60 and 90	Yes