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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-04-30

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.

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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.

Conditions

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Leiomyoma, Uterine Intraoperative Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The patient, the surgeon and the assistant that will collect the data will be masked about the patient's study group.

Study Groups

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Tranexamic acid and group (Group I)

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.

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type DRUG

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.

Saline group (Group II)

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Interventions

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Tranexamic 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.

Intervention Type DRUG

Saline

100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Intervention Type DRUG

Other Intervention Names

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Group I Group II

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes