Clinical trial NCT06114758: Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy
Official title: The Comparison of the Effectiveness of Rectal Misoprostol and Intravenous Tranexamic Acid in Reducing Intraoperative Bleeding in Patients Undergoing Myomectomy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hemorrhage, Surgical
Myoma;Uterus
Effect of Drug
Postoperative Hemorrhage
Postoperative Complications
Keywords: myoma uteri
fibroids
hemmorhage
prostoglandinf2α
tranexamic acid
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-02
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In our study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (Etlik City Hospital) between October 1, 2023, and October 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected prospectively

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of patients' preoperative and postoperative hemogram levels
timeFrame: 24 hours
measure: Comparison of patients' preoperative and postoperative hematocrit levels
timeFrame: 24 hours
measure: Comparison of patients' postoperative shock indices
timeFrame: 6 hour
Secondary outcomes:
measure: Comparison of the patients' postoperative heart rate
timeFrame: 6 hour
measure: Comparison of the patients' postoperative systolic and diastolic blood pressure
timeFrame: 6 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
Study officials:
References: