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

Ankara Etlik City Hospital

Status: Active, not recruiting

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

Treatments: Drug: Cytotec 200Mcg Tablet; Drug: Transamine

Study type: Observational

Funder types: Other

Identifiers

NCT06114758

AEŞH-EK1-2023-383

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 3 patient groups

control group - group 1

Description:

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.

intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2

Description:

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.

Treatment:

Drug: Transamine

intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2

Description:

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.

Treatment:

Drug: Cytotec 200Mcg Tablet