NCT04519593

ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Mother and Child Clinic Saint-Petersburg · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.

Detailed description

Primary endpoints • Assess the volume of blood loss Secondary endpoints * Compare the rates of intra- and postoperative complications, the necessity of blood transfusion, length of surgery, length of hospital and ICU stay, and leiomyoma symptoms relief * Determine the procedure impact on fertility by evaluating the level of anti-mullerian hormone, pregnancy rates, pregnancy complications, and the way of delivery Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach. Sixty patients will undergo laparoscopic myomectomy preceded by temporary uterine blood supply occlusion performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study. Sixty patients will undergo conventional laparoscopic myomectomy performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study. Patients eligible for inclusion, after signing an informed voluntary consent to participate in the study, will be randomized in a 1:1 ratio to the treatment groups using stratification by age, size, and leiomyoma nodes location.

Conditions

• Uterine Leiomyoma
• Uterine Fibroid
• Leiomyoma, Uterine
• Myoma;Uterus
• Laparoscopic Myomectomy
• Postoperative Complications
• Blood Loss, Surgical
• Fertility Issues
• Pregnancy Complications

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic myomectomy with prior temporary uterine blood supply occlusion	Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
PROCEDURE	Conventional laparoscopic myomectomy	Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

Timeline

• Start date: 2020-09-27
• Primary completion: 2022-08-31
• Completion: 2022-11-01
• First posted: 2020-08-19
• Last updated: 2021-07-14

Locations

1 site across 1 country: Russia