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The Comparison of the Effectiveness of Rectal Misoprostol and Intravenous Tranexamic Acid in Reducing Intraoperative Bleeding in Patients Undergoing Myomectomy
Fibroids are the most commonly encountered tumors in the female reproductive system. In patients, fibroids most often lead to abnormal uterine bleeding and the resulting anemia. In some cases, they can cause infertility or habitual abortions. Another complaint caused by fibroids is pain due to pressure and effects on adjacent organs. Very large fibroids can lead to abdominal swelling. Therefore, if a patient becomes symptomatic due to fibroids, myomectomy or, if necessary, hysterectomy is required. Because fibroids have a significant blood supply, there is a high risk of intraoperative bleeding and related complications. Additionally, the most common complication in these patients after the operation is bleeding. In many of these patients, intraoperative or postoperative blood transfusions are performed. If bleeding cannot be intervened early in these patients, hemodynamic instability, shock, coagulopathy, and, in the final stage, death can occur due to hemorrhage. Therefore, both intraoperative and postoperative bleeding control is of vital importance in patients undergoing myomectomy.
In this study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (EŞH) between September 1, 2022, and Sempember 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected. The parameters to be examined in the research are as follows: 1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). 2. Shock indices. 3. Hemogram and hematocrit values at 6-24 hours postoperatively. 4. Duration of the surgery. 5. Adverse effects experienced by the patients. 6. Additional treatments administered. 7. Whether blood transfusion was performed or not. In this study, the G-power analysis program was used to determine the minimum sample size, taking into account a 10% margin of error. According to the analysis results, the minimum number of patients to be included in the study for a total of 75 patients across 3 groups was determined. Statistical analysis of the data obtained in the study will be conducted using the SPSS Statistics 22 software package. A 95% confidence interval will be calculated for each variable, and results will be considered statistically significant for p \< 0.05.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
No
Etlik City Hospital
Ankara, Turkey (Türkiye)
Start Date
September 1, 2023
Primary Completion Date
September 1, 2024
Completion Date
November 1, 2024
Last Updated
November 2, 2023
75
ACTUAL participants
Cytotec 200Mcg Tablet
DRUG
Transamine
DRUG
Lead Sponsor
Ankara Etlik City Hospital
NCT06479655
NCT07335432
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05397652