Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy
Comparing Different Techniques of Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy: A Randomized Controlled Trial
Alexandria University
60 participants
May 1, 2025
INTERVENTIONAL
Conditions
Summary
The current study is a multiple-arm, single blinded, and controlled randomized trial. It will be conducted in two gynecological endoscopy centers: • ElShatby University Hospital, a tertiary level hospital in Alexandria, Egypt. • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt. Patient selection: women with uterine leiomyomata and planning for laparoscopic myomectomy will be assessed for eligibility then will be enrolled in the trial according to the following inclusion and exclusion criteria, after providing a written informed consent of participation. Outcome variables of the study: The primary outcome is intraoperative blood loss and the change in postoperative hemoglobin. The secondary outcomes of this study are the operative time of performing uterine arteries occlusion and the postoperative ovarian reserve.
Eligibility
Inclusion Criteria3
- women with uterine fibroids and complaining of either abnormal uterine bleeding, infertility, urinary or rectosigmoid pressure manifestations.
- Fibroid size from 3 - 10 cm in diameter and with
- a maximum number of 3 fibroids.
Exclusion Criteria8
- contraindication to pneumoperitoneum and laparoscopy,
- patients with BMI \> 30 kg/m2,
- history of midline abdominal incisions,
- women with history of prior ovarian surgery,
- women with history of hormonal treatment for the last 3 months before surgery,
- women who are not good candidate for myomectomy and who would benefit more from hysterectomy such as, women with multiple ≥ 4 leiomyomata, associated adenomyosis, recurrent fibroids after myomectomy.
- suspected endometrial malignancy or suspected leiomyosarcoma features on ultrasound and/or MRI.
- Submucous fibroids who will undergo hysteroscopic myomectomy beside the laparoscopic surgery.
Interventions
Both uterine arteries will be temporary clipped with a Titanium clip till the end of the myomectomy procedure
A "Shoelace" suture will be applied to both uterine arteries and the sutures will be removed at the end of the myomectomy procdure
Permanent coagulation of both uterine arteries will be performed by Bipolar forceps before the start of the myomectomy procedure
No occlusion of uterine arteries will be performed. Only Laparoscopic myomectomy will be performed
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07352761