ProGrip Mesh Repair vs Lichtenstein Operation

Regional Health Center in Kartuzy, Poland

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption); Device: Covidien Parietex ProGrip Self-Fixating Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT02748629

NKBNN/258/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with primary inguinal hernia
• Signed consent

Exclusion criteria

• Recurrent hernia
• Emergency procedure
• Patient not willing to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

ProGrip Mesh Repair

Active Comparator group

Description:

80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation.

Treatment:

Device: Covidien Parietex ProGrip Self-Fixating Mesh

Lichtenstein Operation

Active Comparator group

Description:

80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (<40 g/m2) with standard Lichtenstein technique.

Treatment:

Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption)