ProGrip Mesh Repair vs Lichtenstein Operation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02748629
Study type	Interventional
Source	Regional Health Center in Kartuzy, Poland
Contact
Status	Completed
Phase	N/A
Start date	March 2015
Completion date	October 2016

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