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

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

NCT ID: NCT06114758

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

Conditions: Official terms:
Leiomyoma
Myofibroma
Hemorrhage
Postoperative Complications
Postoperative Hemorrhage
Blood Loss, Surgical
Tranylcypromine
Misoprostol
Tranexamic Acid

Conditions: Keywords:
myoma uteri
fibroids
hemmorhage
prostoglandinf2α
tranexamic acid

Study type: Observational [Patient Registry]

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Cytotec 200Mcg Tablet
Description: the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered
Arm group label: intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2

Other name: misoprostol

Other name: prostoglandin f2α

Intervention type: Drug
Intervention name: Transamine
Description: 1 gram intravenous slow infusion intraoperatively as we start the laparatomy
Arm group label: intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2

Other name: tranexamic acid

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.

Criteria for eligibility:

Study pop:
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

Sampling method: Probability Sample
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

Gender: Female

Gender based: Yes

Gender description: women

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: No

Locations:

Facility:
Name: Etlik City Hospital

Address:
City: Ankara
Country: Turkey

Start date: September 1, 2023

Completion date: November 1, 2024

Lead sponsor:
Agency: Ankara Etlik City Hospital
Agency class: Other

Source: Ankara Etlik City Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06114758