Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). Shock indices. Hemogram and hematocrit values at 6-24 hours postoperatively. Duration of the surgery. Adverse effects experienced by the patients. Additional treatments administered. 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.

Official Title
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The Comparison of the Effectiveness of Rectal Misoprostol and Intravenous Tranexamic Acid in Reducing Intraoperative Bleeding in Patients Undergoing Myomectomy

Conditions
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Hemorrhage, Surgical, Myoma;Uterus, Effect of Drug, Postoperative Hemorrhage, Postoperative Complications

Intervention / Treatment
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* Drug: Cytotec 200Mcg Tablet
* Drug: Transamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age Laparotomic myomectomy surgeries Laparoscopic myomectomy surgeries Exclusion Criteria: Identifying missing or suspicious data related to the patient Administering both intraoperative and postoperative medications to the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group - group 1<br>Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). Shock indices. Hemogram and hematocrit values at 6-24 hours postoperatively. Duration of the surgery. Adverse effects experienced by the patients. Additional treatments administered. Whether blood transfusion was performed or not. | |
| intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2<br>Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). Shock indices. Hemogram and hematocrit values at 6-24 hours postoperatively. Duration of the surgery. Adverse effects experienced by the patients. Additional treatments administered. Whether blood transfusion was performed or not. | Drug: Transamine<br>* 1 gram intravenous slow infusion intraoperatively as we start the laparatomy<br>* Other names: tranexamic acid;|
| intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2<br>Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). Shock indices. Hemogram and hematocrit values at 6-24 hours postoperatively. Duration of the surgery. Adverse effects experienced by the patients. Additional treatments administered. Whether blood transfusion was performed or not. | Drug: Cytotec 200Mcg Tablet<br>* the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered<br>* Other names: prostoglandin f2α;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of patients' preoperative and postoperative hemogram levels | The basal hemogram levels ( gr/dL) of the patients will be compared with the hemogram levels at 6 and 24 hours. | 24 hours | 
| Comparison of patients' preoperative and postoperative hematocrit levels | The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 6 and 24 hours. | 24 hours | 
| Comparison of patients' postoperative shock indices | postoperative 1st, 2nd, and 6th-hour shock indices (heart rate (beats in minute) / systolic blood pressure(mmHg) ) will be compared | 6 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the patients' postoperative heart rate | Patients postoperative 1st, 2nd, and 6th-hour heart rate (beats in minute) will be compared | 6 hour | 
| Comparison of the patients' postoperative systolic and diastolic blood pressure | Patients postoperative 1st, 2nd, and 6th-hour systolic and diastolic blood pressure (mmHg) will be compared | 6 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myoma uteri, fibroids, hemmorhage, prostoglandinf2α, tranexamic acid