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This research is planned as a randomised double-blind controlled trial. interventions to reduce haemorrhage during laparoscopic myomectomy for fiboids is important. İntraoperative Tranexamic acid usage can reduce haemorrhage and related symptoms when given during laparoscopic myomectomy. There is no randomised controlled trials in literature about tranexamic acid usage in laparoscopic gynecological operations.
researchers planned this trial by firstly randomising the patients. 1 gr tranexamic acid in 100 ml salin will bi given by initial of the anesthesia of the patient, the other group will be taken only 100ml saline solution. Randomising will be double blind and only anesthesiologist will see if the paient is in working group or control group. Than researchers provide laparoscopic myomectomy with same prothocol to each patient. At the end of the operation, researchers will record all the parameters during operation like; operation starting and ending time, the amount of bleeding, time of suturing, the size, location and count of myoma uteri, complications, weight of myoma uteri and the change of haemoglobine levels before and after operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRANEXAMİC ACİD | Experimental | . 1 gr tranexamic acid in 100 ml salin given in 15 minutes |
|
| NO TRANEXAMİC ACİD | Placebo Comparator | 100 ml salin solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 100 MG/ML | Drug | 1 GR TRANEXAMİC ACİD İN 100 ML SALİNE SOLUTİON GİVEN İN 15 MİNUTES |
|
| Measure | Description | Time Frame |
|---|---|---|
| amount of bleeding during operation | total amount of bleeding during surgery | 0 minute - 180 minute |
| operation duration time | time between initial and end of the surgery | 0 minute - 180 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MERAL TUĞBA ÇİMŞİR | Contact | 05064742272 | dr.tugbaacar@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alku Alanya Education and Research Hospital | Antalya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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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PROSPECTİVELY DOUBLE-BLİND RANDOMİSED CONTROLLED TRİAL
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| Placebos | Drug | 100 ML SALİNE SOLUTİON |
|
| D009372 | Neoplasms, Connective Tissue |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |