Intraoperative Blood Loss, Leiomyoma, Uterine
Conditions
Keywords
Leiomyoma, Laparoscopic myomectomy, Tranexamic acid, Blood loss, İntramyometrial desmopressin
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.
Interventions
DRUGTranexamic acid
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.
DRUGSaline
100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The patient, the surgeon and the assistant that will collect the data will be masked about the patient's study group.
Intervention model description
Prospective randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
1. Patients who are planned to undergo different surgery along with myomectomy 2. Those with a diagnosis and suspicion of malignancy 3. Those with a history of thromboembolic disease 4. Those with cardiac, hepatic or renal disease 5. Those with a body mass index of 30 and above 6. Patients with abnormal coagulation test results 7. Patients using anticoagulants 8. Those who use drugs or diseases that may affect coagulation (serum creatinine \> 1.5 mg/dL) 9. Those allergic to tranexamic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed