Acibadem Maslak Hospital
Istanbul, Sariyer, 34457, Turkey (Türkiye)
NCT Number: NCT05517590
To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.
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Notify Me18 year–60 year
Female
Interventional
Not applicable
Istanbul, Sariyer, 34457, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Group I
100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.
Other names: Group II
Time frame: 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.
Time frame: On postoperative day 0 and day 2
Preoperative and postoperative hemoglobin values will be recorded.
Time frame: Postoperative day 1
Patients who received postoperative blood transfusions will be recorded.
Time frame: At the end of the operation.
Operation time will be recorded.
Time frame: At postoperative first week and 3rd month.
Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.
Acibadem University
Other
Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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