ProGrip Mesh Repair vs Lichtenstein Operation

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: Covidien Parietex ProGrip Self-Fixating Mesh; Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption)

• Registration Number: NCT02748629
• Lead Sponsor: Regional Health Center in Kartuzy, Poland

Brief 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Primary Completion: 2016-05
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• All patients with primary inguinal hernia
• Signed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProGrip Mesh Repair	Covidien Parietex ProGrip Self-Fixating Mesh	80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation.
Lichtenstein Operation	Lightweight Polypropylene Mesh (<38g/m2 after absorption)	80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (\<40 g/m2) with standard Lichtenstein technique.

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative pain and its intensity using VAS Scale	12 Months	Assessment will be made using Visual Analogue Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Rate of foreign body sensation - Subjective feeling of discomfort in the groin	12 Months	Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire.
Duration of surgery	Day of surgery
Hernia recurrence rate	12 Months	Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)
Post-operative complications	12 Months	Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain)
Incidence of Treatment-Emergent Adverse Events [Safety]	12 Months

Trial Locations

Locations (1)

Regional Health Center in Kartuzy; 🇵🇱 Kartuzy, Poland