ProGrip Mesh Repair vs Lichtenstein Operation

Regional Health Center in Kartuzy, Poland143 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

143

Conditions

Inguinal Hernia

Interventions

Covidien Parietex ProGrip Self-Fixating MeshDEVICE

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

Serag Wiessner SERAMESH® PA 15x10 cm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients with primary inguinal hernia * Signed consent Exclusion Criteria: * Recurrent hernia * Emergency procedure * Patient not willing to participate

Locations (1)

Regional Health Center in Kartuzy

Kartuzy, Poland

Outcomes

Primary Outcomes

Incidence of post-operative pain and its intensity using VAS Scale

Assessment will be made using Visual Analogue Scale (VAS).

Time frame: 12 Months

Secondary Outcomes

Rate of foreign body sensation - Subjective feeling of discomfort in the groin

Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire.

Time frame: 12 Months

Hernia recurrence rate

Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)

Time frame: 12 Months

Post-operative complications

Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain)

Time frame: 12 Months

Duration of surgery

Time frame: Day of surgery

Incidence of Treatment-Emergent Adverse Events [Safety]

Time frame: 12 Months

Data from ClinicalTrials.gov

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