drugset / Trial / NCT05806307

Methods Decreasing Bleeding in Open Myomectomy

NCT05806307

Phase 4 Unknown 105 enrolled Cairo University
RandomizedParallel-groupDouble-blindSupportive care

Summary

Uterine leiomyomas (fibroids or myomas) are benign, smooth muscle tumors of the human uterus. Most myomas are asymptomatic (symptomless) and are discovered incidentally during a routine pelvic examination or imaging studies and have a lifetime incidence of approximately 70% in the general population . However, Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. The most common clinical symptoms include abnormal uterine bleeding, dysmenorrhea, pelvic pain, infertility, and recurrent pregnancy loss The standard treatment of symptomatic leiomyomas is Abdominal myomectomy Blood loss during myomectomy can be intra-operative or postoperative and with hematoma formation. The average volume of blood loss during abdominal myomectomy is 200 to 800 ml. massive blood loss associated with the dissection of huge fibroids renders myomectomy a more technically challenging procedure than hysterectomy. Sometimes myomectomy is converted to hysterectomy intra-operatively when bleeding becomes heavy and uncontrollable or when it is impossible to reconstruct the uterus because of the many defects left by removal of multiple myomas . Many techniques are used to reduce blood loss during myomectomy; preoperative measures such as correction of preoperative anemia associated with menorrhagia may be treated with iron supplementation, use of gonadotropin (GHG) triggers prior to surgery. Intra-operative measures as use of tourniquet around the uterus during the operation, injections of Vasopressin or other vasopressors as epinephrine in the uterine muscle and use of ecbolic (misoprostol, oxytocin, and carbetocin etc.). Uterine artery ligation, embolization, or internal iliac artery ligation may also be used to avoid hysterectomy when heavy bleeding is anticipated or occurs during myomectomy

Timeline

Start
2023-03-15
Primary completion
2023-10-30
Completion
2023-11-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 50 ml Other
Comparator Carbetocin Peptide 100 ug Other
Comparator Epinephrine Other / unclassified 0.5 mg Other
Comparator Etamsylate Unknown 500 mg Intravenous
Comparator Misoprostol Other / unclassified 800 ug Rectal
Comparator Oxytocin Peptide 40 iu Other
Comparator Terlipressin Peptide 20 iu Other
Comparator Tranexamic Acid Small molecule 1 g Intravenous