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NCT01003509 Clinical Trial

A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial

Hernia Clinical Trial

— herni  

Official title:
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01003509
Other study ID # hernia
Secondary ID aysan
Status Recruiting
Phase N/A
First received October 27, 2009
Last updated May 3, 2011
Start date January 2001
Est. completion date January 2012

Study information
Verified date October 2009
Source SB Istanbul Education and Research Hospital
Contact erhan mr aysan, assoc. prof.
Phone +902125884400
Email dr@webcerrah.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

This is a new inguinal hernia repair technique.

Description:

In this study we are revealing a new inguinal hernia repair technique. It is constructed from two layers. Deep layer is modified Shouldice technique, the other superficial one is moloney technique.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2012
Est. primary completion date January 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years to 90 Years
Eligibility Inclusion Criteria:

- Inguinal hernia

Exclusion Criteria:

- Recurrences, child

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• modified shouldice and double
one arm modified shouldice, other one is double repair

Locations
Country Name City State
Turkey S.B. Istanbul Educational & Teaching Hospital Istanbul Marmara

Sponsors (1)
Lead Sponsor Collaborator
SB Istanbul Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary complications, recurrences 6 month Yes
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