Myomectomy Clinical Trial
Official title:
Safety and Efficacy of Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy; A Randomized Controlled Trial
Verified date | April 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Uterine leiomyomas (fibroids) are the most common benign tumors among women. Fibroids are found in approximately 20% of women over 35 years of age. In 20-50% of patients, fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract. Surgery is indicated for symptomatic uterine leiomyomas; hysterectomy for women who have completed childbearing (women > 40 years old), and myomectomy for women <40 years old who wish to preserve uterus and fertility.
Status | Completed |
Enrollment | 150 |
Est. completion date | March 15, 2020 |
Est. primary completion date | February 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - • Age group (18-50) years old - Intramural or interstitial myomas (more than 5 cm) - Symptomatic myomas (heavy menstrual bleeding or pain during menstruation) - Abdominal myomectomy - No medical disorders - No coagulation disorders Exclusion Criteria: - • Age group (less than 18 yrs old) - Age group (more than 50 yrs old) - Subserous or submucous myomas - Laparoscopic or hysteroscopic myomectomy - Medical disorders (for example uncontrolled hypertension, diabetes mellitus, renal or hepatic disorders) - Coagulation disorders - Previous use of anticoagulant drugs - Previous myomectomy - Allergy to Tranexamic acid or oxytocin - Malignant features by U/S or examination - Pregnancy - Previous hormonal therapy (GnRH analogues) |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of medicine Cairo university | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative Blood loss | The total volume of intraoperative blood loss was estimated by measuring the amount of blood accumulated in the aspiration equipment and the amount of blood on the surgical gauze using an alkaline hematin technique | during the operation | |
Secondary | Operation time | Operation time from skin incision to skin closure in minutes. | 1 hour | |
Secondary | Myomectomy time | Myomectomy time from first uterine incision to closure of last uterine incision in minutes | 30 minutes |
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