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Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.
A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.
Two techniques of inguinal hernia repair will be evaluated:
Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selfgrip mesh | Procedure | inguinal hernia repair using a selfgrip mesh |
| |
| Measure | Description | Time Frame |
|---|---|---|
| chronic pain | 3 months, 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| morbidity | 3 months, 15 months | |
| recurrence rate | 3 months and 15 months | |
| quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Prager, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Feldkirch, Dept. of Surgery | Feldkirch | Austria | ||||
| Hospital Barmherzige Schwestern |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| lightweight mesh with suture fixation |
| Procedure |
inguinal hernia repair using a lightweight mesh with suture fixation |
|
| 3 months and 15 months |
| Linz |
| Austria |
| LK Weinviertel Mistelbach, Surgical Department | Mistelbach | Austria |
| KH Göttlicher Heiland | Vienna | 1170 | Austria |
| KFJ Hospital, Dept. of Surgery | Vienna | Austria |
| Medical University of Vienna, Dept. of Surgery | Vienna | Austria |
| KH Wiener Neustadt, Surgical Department | Wiener Neustadt | Austria |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |