Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

Study Overview
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Brief Summary
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To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

Detailed Description
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Although complication rates such as bleeding are observed to be low in surgeries performed by experienced surgeons, sometimes severe bleeding that may require emergency blood transfusion can be encountered during myomectomy operation. Therefore, various medical treatments such as vasopressin, misoprostol, ascorbic acid are still being sought to reduce the amount of intraoperative bleeding. Tranexamic acid is a lysine-derived drug with an antifibrinolytic effect, which has been used for a long time, especially in orthopedic and cardiovascular surgeries, to stop bleeding and reduce the need for blood transfusions, and is often well tolerated and has few side effects. It has a good safety profile with the Food and Drug Administration (FDA) Pregnancy Category B and is a drug frequently used in postpartum hemorrhage. It is also used to reduce bleeding in bleeding observed in many gynecological surgeries such as hypermenorrhea, bleeding in intrauterine device application and cervical conization. In the investigator's clinic, intramyometrial desmopressin administration is routinely used in most cases. Although the application of various intraoperative medical treatments in laparoscopic myomectomies has been examined in the literature, there are not enough prospective studies investigating the administration of desmopressin and intravenous tranexamic acid. In the investigator's study, investigators plan to evaluate the effect of the combined use of these two drugs on intraoperative bleeding and the need for blood transfusion compared to placebo.

Official Title
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Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Leiomyoma, Uterine, Intraoperative Blood Loss

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study. Exclusion Criteria: Patients who are planned to undergo different surgery along with myomectomy Those with a diagnosis and suspicion of malignancy Those with a history of thromboembolic disease Those with cardiac, hepatic or renal disease Those with a body mass index of 30 and above Patients with abnormal coagulation test results Patients using anticoagulants Those who use drugs or diseases that may affect coagulation (serum creatinine > 1.5 mg/dL) Those allergic to tranexamic acid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid and group (Group I)<br>In Group I, 1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time. | Drug: Tranexamic acid<br>* 1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.<br>* Other names: Group I;|
| Placebo Comparator: Saline group (Group II)<br>Group II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time. | Drug: Saline<br>* 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.<br>* Other names: Group II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss | The amount of perioperative bleeding will be calculated by measuring the blood volume in the suction device and subtracting the irrigation fluid from the total amount. | At the end of the surgery. | 
| Preoperative and postoperative hemoglobin change | Preoperative and postoperative hemoglobin values will be recorded. | On postoperative day 0 and day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for postoperative blood transfusion | Patients who received postoperative blood transfusions will be recorded. | Postoperative day 1 | 
| Operation time | Operation time will be recorded. | At the end of the operation. | 
| Postoperative thrombosis symptoms | Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month. | At postoperative first week and 3rd month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyoma, Laparoscopic myomectomy, Tranexamic acid, Blood loss, İntramyometrial desmopressin