Inguinal Hernia
Conditions
Keywords
inguinal hernia, mesh, lichtenstein, hernia repair, selfgripping mesh
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.
Interventions
DEVICECovidien Parietex ProGrip Self-Fixating Mesh
DEVICELightweight Polypropylene Mesh (<38g/m2 after absorption)
Serag Wiessner SERAMESH® PA 15x10 cm
Sponsors
Medical University of Gdansk
Regional Health Center in Kartuzy, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with primary inguinal hernia * Signed consent
Exclusion criteria
* Recurrent hernia * Emergency procedure * Patient not willing to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-operative pain and its intensity using VAS Scale | 12 Months | Assessment will be made using Visual Analogue Scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| Duration of surgery | Day of surgery | — |
| Incidence of Treatment-Emergent Adverse Events [Safety] | 12 Months | — |
Countries
Poland
Outcome results
None listed