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| ID | Type | Description | Link |
|---|---|---|---|
| KUH 31//2012 | Registry Identifier | KUH 31//2012 |
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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Paijat-Hame Hospital District | OTHER |
| North Karelia Central Hospital | OTHER |
| East Savo Hospital District |
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This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.
Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glue fixation | Experimental | Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros) |
|
| self-gripping | Active Comparator | ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros) |
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| suture fixation | Active Comparator | Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histoacryl | Device | cyanoacrylate glue fixation of mesh 1 ml |
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| Measure | Description | Time Frame |
|---|---|---|
| pain | pain scores (VAS 0-10) preoperatively and after surgery | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| costs | operative cost-effectiveness | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannu EK Paajanen, MD, PhD | Contact | +358-40-3589905 | hannu.paajanen@kuh.fi | |
| Kirsi Rönkä, MD | Contact | kirsi.ronka@kuh.fi |
| Name | Affiliation | Role |
|---|---|---|
| Hannu EK Paajanen, MD, PhD | Kuopio University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Recruiting | Kuopio | 70600 | Finland |
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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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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| OTHER |
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| Progrip | Device | self-gripping mesh |
|
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| sutures (prolene 3-0) | Device | non-absorbable suture fixation 3-0 |
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