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In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin glue | Active Comparator |
| |
| Tacks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin glue | Procedure | Tissucol 2 ml |
| |
| Tacks |
| Measure | Description | Time Frame |
|---|---|---|
| Early pain after operation | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| haematoma in groin region | day 10 | |
| seroma in groin region | day 10 | |
| fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette A Tolver, M.D. | University Hospital Koege | Principal Investigator |
| Thue Bisgaard, M.D. DMSc | University Hospital Koege | Principal Investigator |
| Poul Juul, M.D. | Private Hospital Hamlet | Principal Investigator |
| Jacob Rosenberg, M.D. DMSc | Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Hospital Hamlet | Søborg | 2160 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23355162 | Derived | Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013 Aug;27(8):2727-33. doi: 10.1007/s00464-012-2766-6. Epub 2013 Jan 26. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006550 | Hernia, Femoral |
| D010146 | Pain |
| D049291 | Seroma |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Procedure |
Protacks |
|
| 10 days |
| discomfort | 6 month |
| Postoperative nausea and vomiting (PONV) | 10 days |
| Use of Analgesics at PACU | 1 day |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D006470 | Hemorrhage |