NCT00827944

Parietex Progrip Study

ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 603 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: Male
• Age: 31 Years – 74 Years
• Healthy volunteers: Not accepted

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 polypropylene mesh.

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 lightweight Polypropylene meshes requiring fixation by sutures. * Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study. * 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.

Conditions

• Hernia, Inguinal

Interventions

Type	Name	Description
DEVICE	Parietex Progrip	Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
DEVICE	Low weight polypropylene mesh	Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-01-23
• Last updated: 2016-11-17
• Results posted: 2016-11-17

Locations

9 sites across 5 countries: Belgium, Germany, Netherlands, Sweden, United Kingdom