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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sutured mesh | Experimental | 200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair) |
|
| non-sutured mesh | Experimental | 200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open inguinal hernia repair | Device | Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complaints | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaana Vironen, MD PhD | HUCH Jorvi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUCH Jorvi Hospital, department of Surgery | Espoo | 02480 | Finland | |||
| HUCH Surgical Hospital, Dept of Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22362035 | Derived | Pierides G, Scheinin T, Remes V, Hermunen K, Vironen J. Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Br J Surg. 2012 May;99(5):630-6. doi: 10.1002/bjs.8705. Epub 2012 Feb 23. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Helsinki |
| Finland |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |