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

October 31, 2023 updated by: Tuğba Ağbal, Ankara Etlik City Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Drug: Transamine
1 gram intravenous slow infusion intraoperatively as we start the laparatomy
Other Names:
  • tranexamic acid
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.
Drug: Cytotec 200Mcg Tablet
the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered
Other Names:
  • misoprostol
  • prostoglandin f2α

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of patients' preoperative and postoperative hemogram levels
Time Frame: 24 hours
The basal hemogram levels ( gr/dL) of the patients will be compared with the hemogram levels at 6 and 24 hours.
24 hours
Comparison of patients' preoperative and postoperative hematocrit levels
Time Frame: 24 hours
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 6 and 24 hours.
24 hours
Comparison of patients' postoperative shock indices
Time Frame: 6 hour
postoperative 1st, 2nd, and 6th-hour shock indices (heart rate (beats in minute) / systolic blood pressure(mmHg) ) will be compared
6 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the patients' postoperative heart rate
Time Frame: 6 hour
Patients postoperative 1st, 2nd, and 6th-hour heart rate (beats in minute) will be compared
6 hour
Comparison of the patients' postoperative systolic and diastolic blood pressure
Time Frame: 6 hour
Patients postoperative 1st, 2nd, and 6th-hour systolic and diastolic blood pressure (mmHg) will be compared
6 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK1-2023-383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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