The Comparison of the Effectiveness of Rectal Misoprostol and Intravenous Tranexamic Acid in Reducing Intraoperative Bleeding in Patients Undergoing Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Comparison of patients' postoperative shock indices
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Laparotomic myomectomy surgeries
- •Laparoscopic myomectomy surgeries
排除标准
- •Identifying missing or suspicious data related to the patient
- •Administering both intraoperative and postoperative medications to the patient
研究组 & 干预措施
intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2
- 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.
干预措施: Transamine (Drug)
intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2
- 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.
干预措施: Cytotec 200Mcg Tablet (Drug)
结局指标
主要结局
Comparison of patients' postoperative shock indices
时间窗: 6 hour
postoperative 1st, 2nd, and 6th-hour shock indices (heart rate (beats in minute) / systolic blood pressure(mmHg) ) will be compared
Comparison of patients' preoperative and postoperative hemogram levels
时间窗: 24 hours
The basal hemogram levels ( gr/dL) of the patients will be compared with the hemogram levels at 6 and 24 hours.
Comparison of patients' preoperative and postoperative hematocrit levels
时间窗: 24 hours
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 6 and 24 hours.
次要结局
- Comparison of the patients' postoperative heart rate(6 hour)
- Comparison of the patients' postoperative systolic and diastolic blood pressure(6 hour)
研究者
Tuğba Ağbal
clinical doctor
Ankara Etlik City Hospital