Prevention of Hemorrhagic Risk in Upper Myomectomy Using Oral Misoprostol with Uterine Artery Occlusion

What this Trial Is About

This research aims to evaluate the use of oral misoprostol combined with transient occlusion of the uterine arteries to reduce bleeding during laparoscopic or laparotomic myomectomy surgery in women with uterine fibroids. Uterine fibroids are the most common benign tumors in women of childbearing age, and about 30% cause symptoms such as heavy bleeding, anemia, or pain that require surgical removal. The study investigates whether misoprostol, known for its muscle-contracting effects and good tolerance, can help minimize intraoperative bleeding when used alongside surgical artery occlusion. Participants will undergo myomectomy either by laparoscopy or laparotomy based on fibroid size and number. They will receive either 400 mcg of misoprostol orally or a placebo before surgery, with transient occlusion of the uterine arteries applied during the procedure. The study compares bleeding amounts during surgery between the misoprostol and placebo groups, regardless of surgical technique. This randomized trial uses a quadruple-blind design to assess the effects of misoprostol combined with artery occlusion. During the study, researchers will measure blood loss during surgery, hemoglobin levels before and on the day of surgery, and post-operative outcomes such as pain levels, transfusion rates, complications, and hospital stay duration. Patient characteristics like age, body mass index, medical history, and fibroid details will also be compared between groups and surgery types. Follow-up assessments will continue up to one month after surgery, with safety monitored for up to eight weeks. Total participation spans pre-surgery evaluation through post-operative recovery and monitoring.

Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.