NCT02748629

ProGrip Mesh Repair vs Lichtenstein Operation

Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Regional Health Center in Kartuzy, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.

Detailed description

Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively. Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	Covidien Parietex ProGrip Self-Fixating Mesh
DEVICE	Lightweight Polypropylene Mesh (<38g/m2 after absorption)	Serag Wiessner SERAMESH® PA 15x10 cm

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-05-01
• Completion: 2016-10-01
• First posted: 2016-04-22
• Last updated: 2016-10-06

Locations

1 site across 1 country: Poland