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

Postoperative Complications Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04519593
Study type Interventional
Source Mother and Child Clinic Saint-Petersburg
Contact Andrei Dubinin, MD, PhD
Phone +79811506112
Email andub@mail.ru
Status Recruiting
Phase N/A
Start date September 27, 2020
Completion date November 1, 2022
View Details
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