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

Mother and Child Clinic Saint-Petersburg

Status: Unknown

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

Treatments: Procedure: Conventional laparoscopic myomectomy; Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04519593

MCCSPb-8-12-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic uterine leiomyoma
• Size of leiomyoma node >5 cm based on imaging
• Leiomyoma node types 3, 4, 5, 6 according to The International Federation of Gynecology and Obstetrics (FIGO) classification or type 2 not feasible to be removed during hysteroscopy
• Single or multiple nodes
• Absent contraindications for laparoscopic myomectomy
• Voluntarily signed informed consent to participate in the study

Exclusion criteria

• Age < 18 years
• Asymptomatic uterine leiomyoma
• Size of leiomyoma node <5 cm based on imaging
• Absence of leiomyoma node types 3, 4, 5, 6 according to FIGO classification and type 2 not feasible to be removed during hysteroscopy
• Planned simultaneous hysteroscopy with leiomyoma node excision
• Current pregnancy and breastfeeding
• Suspicion of a malignant uterine tumor
• Prior uterine leiomyoma surgery
• Contraindications for laparoscopic myomectomy
• Lack of decision-making capacity hindering signing the consent to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Laparoscopic myomectomy with temporary blood supply occlusion

Experimental group

Description:

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

Treatment:

Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion

Conventional laparoscopic myomectomy

Active Comparator group

Description:

Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.

Treatment:

Procedure: Conventional laparoscopic myomectomy