Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 143
- Locations
- 2
- Primary Endpoint
- Incidence of post-operative pain and its intensity using VAS Scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients with primary inguinal hernia
- •Signed consent
Exclusion Criteria
- •Recurrent hernia
- •Emergency procedure
- •Patient not willing to participate
Outcomes
Primary Outcomes
Incidence of post-operative pain and its intensity using VAS Scale
Time Frame: 12 Months
Assessment will be made using Visual Analogue Scale (VAS).
Secondary Outcomes
- Rate of foreign body sensation - Subjective feeling of discomfort in the groin(12 Months)
- Duration of surgery(Day of surgery)
- Hernia recurrence rate(12 Months)
- Post-operative complications(12 Months)
- Incidence of Treatment-Emergent Adverse Events [Safety](12 Months)