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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06114758
• Other study ID #: AESH-EK1-2023-383
• Status: Active, not recruiting
• Start date: September 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2023
• Source: Ankara Etlik City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: November 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Effect of Drug
• Hemorrhage
• Hemorrhage, Surgical
• Leiomyoma
• Myoma;Uterus
• Postoperative Complications
• Postoperative Hemorrhage

Intervention

Drug:
• Cytotec 200Mcg Tablet
the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered
• Transamine
1 gram intravenous slow infusion intraoperatively as we start the laparatomy

Locations

Country	Name	City	State
Turkey	Etlik City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Comparison of the patients' postoperative heart rate	Patients postoperative 1st, 2nd, and 6th-hour heart rate (beats in minute) will be compared	6 hour
Secondary	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