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Sinus surgery is a common, day surgery procedure performed by general and subspecialty trained otolaryngologists. In most cases, this is a safe surgery with a low incidence of complications. When there is significant bleeding or enough bleeding to obscure important anatomical landmarks, there is a higher chance of complications. These complications can include blindness, meningitis or cerebrospinal fluid leak. Our hypothesis is that in patients taking oral tranexamic acid three days before surgery and six days after, there will be less intraoperative bleeding, better surgical visualization and less postoperative bleeding events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Experimental | This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery. |
|
| A | Placebo Comparator | This will be the control group which will take the placebo medication for 3 days before and six days after their functional endoscopic sinus surgery (FESS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding amount | During the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical visualization scoring | During the surgery | |
| Postoperative bleeding events | Six days after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad D Mechor, MD | Division of Otolaryngology, University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockyview General Hospital | Calgary | Alberta | T2V 1P9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10187931 | Background | Osguthorpe JD. Surgical outcomes in rhinosinusitis: what we know. Otolaryngol Head Neck Surg. 1999 Apr;120(4):451-3. doi: 10.1053/hn.1999.v120.a95228. No abstract available. | |
| 5971474 | Background | Blumenfeld RJ, Skolnik EM. Intracranial complications of sinus disease. Trans Am Acad Ophthalmol Otolaryngol. 1966 Nov-Dec;70(6):899-908. No abstract available. |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery |
|
| 2000009 | Background | Clayman GL, Adams GL, Paugh DR, Koopmann CF Jr. Intracranial complications of paranasal sinusitis: a combined institutional review. Laryngoscope. 1991 Mar;101(3):234-9. doi: 10.1288/00005537-199103000-00003. |
| 7359985 | Background | Morgan PR, Morrison WV. Complications of frontal and ethmoid sinusitis. Laryngoscope. 1980 Apr;90(4):661-6. doi: 10.1288/00005537-198004000-00013. |
| 7923850 | Background | Cumberworth VL, Sudderick RM, Mackay IS. Major complications of functional endoscopic sinus surgery. Clin Otolaryngol Allied Sci. 1994 Jun;19(3):248-53. doi: 10.1111/j.1365-2273.1994.tb01225.x. |
| 539747 | Background | Goldwyn RM. Unexpected bleeding after elective nasal surgery. Ann Plast Surg. 1979 Mar;2(3):201-4. doi: 10.1097/00000637-197903000-00004. |
| 10400410 | Background | Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017. |
| 16686395 | Background | Yaniv E, Shvero J, Hadar T. Hemostatic effect of tranexamic acid in elective nasal surgery. Am J Rhinol. 2006 Mar-Apr;20(2):227-9. |
| 7526811 | Background | Fremes SE, Wong BI, Lee E, Mai R, Christakis GT, McLean RF, Goldman BS, Naylor CD. Metaanalysis of prophylactic drug treatment in the prevention of postoperative bleeding. Ann Thorac Surg. 1994 Dec;58(6):1580-8. doi: 10.1016/0003-4975(94)91636-5. |
| 12063454 | Background | Casati V, Sandrelli L, Speziali G, Calori G, Grasso MA, Spagnolo S. Hemostatic effects of tranexamic acid in elective thoracic aortic surgery: a prospective, randomized, double-blind, placebo-controlled study. J Thorac Cardiovasc Surg. 2002 Jun;123(6):1084-91. doi: 10.1067/mtc.2002.120717. |
| 16270608 | Background | Wormald PJ, van Renen G, Perks J, Jones JA, Langton-Hewer CD. The effect of the total intravenous anesthesia compared with inhalational anesthesia on the surgical field during endoscopic sinus surgery. Am J Rhinol. 2005 Sep-Oct;19(5):514-20. |