Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Hemorrhage

Postoperative Complications

Leiomyoma

Infertility

Pregnancy Complications

Myofibroma

Blood Loss, Surgical

Myoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Intraoperative Complications

Genital Diseases

Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.

Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.

Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.

Laparoscopic myomectomy with prior temporary uterine blood supply occlusion

Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

Conventional laparoscopic myomectomy

Andrei Dubinin, MD, PhD

Pavel Sorokin, MD

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.

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.

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.

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

Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief

Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma	NCT04519593	Uterine Leiomyo... Uterine Fibroid Leiomyoma, Uter... Myoma;Uterus Laparoscopic My... Postoperative C... Blood Loss, Sur... Fertility Issue... Pregnancy Compl...	Laparoscopic my... Conventional la...	18 Years -	Mother and Child Clinic Saint-Petersburg
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma	NCT04519593	Uterine Leiomyo... Uterine Fibroid Leiomyoma, Uter... Myoma;Uterus Laparoscopic My... Postoperative C... Blood Loss, Sur... Fertility Issue... Pregnancy Compl...	Laparoscopic my... Conventional la...	18 Years -	Mother and Child Clinic Saint-Petersburg

Spots Global Cancer Trial Database for temporary uterine blood supply occlusion