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| Name | Class |
|---|---|
| Medical University of Gdansk | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProGrip Mesh Repair | Active Comparator | 80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation. |
|
| Lichtenstein Operation | Active Comparator | 80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (<40 g/m2) with standard Lichtenstein technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covidien Parietex ProGrip Self-Fixating Mesh | Device |
| ||
| Lightweight Polypropylene Mesh (<38g/m2 after absorption) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative pain and its intensity using VAS Scale | Assessment will be made using Visual Analogue Scale (VAS). | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
| Hernia recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mateusz T Zamkowski, MD | Regional Health Center in Kartuzy, Department of General Surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Health Center in Kartuzy | Kartuzy | 83-300 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25146918 | Result | Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
Serag Wiessner SERAMESH® PA 15x10 cm |
|
Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)
| 12 Months |
| Post-operative complications | Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain) | 12 Months |
| Duration of surgery | Day of surgery |
| Incidence of Treatment-Emergent Adverse Events [Safety] | 12 Months |