Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.
- Conditions
- Leiomyoma, UterineIntraoperative Blood Loss
- Interventions
- Drug: Saline
- Registration Number
- NCT05517590
- Lead Sponsor
- Acibadem University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 102
- Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline group (Group II) Saline 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. Tranexamic acid and group (Group I) Tranexamic acid 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.
- Primary Outcome Measures
Name Time Method Perioperative blood loss At the end of the surgery. 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.
Preoperative and postoperative hemoglobin change On postoperative day 0 and day 2 Preoperative and postoperative hemoglobin values will be recorded.
- Secondary Outcome Measures
Name Time Method Need for postoperative blood transfusion Postoperative day 1 Patients who received postoperative blood transfusions will be recorded.
Operation time At the end of the operation. Operation time will be recorded.
Postoperative thrombosis symptoms At postoperative first week and 3rd month. Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.
Trial Locations
- Locations (1)
Acibadem Maslak Hospital
🇹🇷Istanbul, Sariyer, Turkey
Acibadem Maslak Hospital🇹🇷Istanbul, Sariyer, Turkey