Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAlexandria University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

contraindication to pneumoperitoneum and laparoscopy,

patients with BMI > 30 kg/m2,

history of midline abdominal incisions,

women with history of prior ovarian surgery,

Trial design

Treatments tested in this trial

  • Temporary clipping of uterine artery
  • Temporary occlusive suturing of uterine artery
  • Bipolar coagulation of uterine arteries
  • Laparoscopic myomectomy only

Treatment groups

60 Participants
are divided into 4 treatment groups

Sponsors and collaborators