Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy
NCT ID: NCT06114758
Last Updated: 2023-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2023-09-01
2024-11-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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control group - group 1
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.
No interventions assigned to this group
intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2
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.
Transamine
1 gram intravenous slow infusion intraoperatively as we start the laparatomy
intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2
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.
Cytotec 200Mcg Tablet
the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Laparotomic myomectomy surgeries
* Laparoscopic myomectomy surgeries
Exclusion Criteria
* Administering both intraoperative and postoperative medications to the patient
18 Years
45 Years
FEMALE
No
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Tuğba Ağbal
clinical doctor
Locations
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Etlik City Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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AEŞH-EK1-2023-383
Identifier Type: -
Identifier Source: org_study_id
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