faculty of medicine Cairo university
Giza, 11231, Egypt
NCT Number: NCT03892668
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.
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Notify Me18 year–50 year
Female
Interventional
Phase 4
Giza, 11231, Egypt
Interventions:
Preoperative
Intra Operative
Postoperative
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure.
An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure.
An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the Oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation
Time frame: during the operation
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
Time frame: 1 hour
Operation time from skin incision to skin closure in minutes.
Time frame: 30 minutes
Myomectomy time from first uterine incision to closure of last uterine incision in minutes
Cairo University
Other
Safety and Efficacy of Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy; A Randomized Controlled Trial
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