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

NCT06114758 | Unknown DMC

• 1 other identifier: AEŞH-EK1-2023-383
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

myoma uteri; fibroids; hemmorhage; prostoglandinf2α; tranexamic acid

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Comparison of the patients' postoperative heart rate

  6 hour

• Comparison of the patients' postoperative systolic and diastolic blood pressure

  6 hour

Study Arms (3)

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

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

Interventions

Cytotec 200Mcg Tablet DRUG

the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered

Also known as: misoprostol, prostoglandin f2α

intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2

Transamine DRUG

1 gram intravenous slow infusion intraoperatively as we start the laparatomy

Also known as: tranexamic acid

intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Patients over 18 years of age
• Laparotomic myomectomy surgeries
• Laparoscopic myomectomy surgeries

You may not qualify if:

• Identifying missing or suspicious data related to the patient
• Administering both intraoperative and postoperative medications to the patient

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Myofibroma; Postoperative Hemorrhage; Postoperative Complications; Leiomyoma

Interventions

Misoprostol; Tablets; Tranylcypromine; Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Dosage Forms; Pharmaceutical Preparations; Propylamines; Amines; Organic Chemicals; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 2, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)