Status:
COMPLETED
Parietex Progrip Study
Lead Sponsor:
Medtronic - MITG
Conditions:
Hernia, Inguinal
Eligibility:
MALE
31-74 years
Phase:
PHASE4
Brief Summary
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight ...
Detailed Description
* Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. * Patients in Lichtenstein group will be treated with l...
Eligibility Criteria
Inclusion
- All male patients at participating centers with a primary, uncomplicated inguinal hernia.
- Collar of the defect ≤ 4 cm
- Signed informed consent
Exclusion
- 30 years ≥ Age ≥ 75 years
- Emergency procedure
- Inclusion in other trials
- Bilateral inguinal hernia
- Recurrence
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
603 Patients enrolled
Trial Details
Trial ID
NCT00827944
Start Date
October 1 2008
End Date
October 1 2012
Last Update
November 17 2016
Active Locations (9)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
2
Klinikum Bremen-Mitte
Bremen, Germany, 28177
3
Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik
Fulda, Germany, D- 36039 Fulda
4
Catharina-ziekenhuis
Eindhoven, Netherlands, 5623 EJ