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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04519593
• Other study ID #: MCCSPb-8-12-2020
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2021
• Source: Mother and Child Clinic Saint-Petersburg
• Contact: Andrei Dubinin, MD, PhD
• Phone: +79811506112
• Email: andub[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 1, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Conventional laparoscopic myomectomy
Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

Locations

Country	Name	City	State
Russian Federation	Mother and Child Clinic Saint-Petersburg	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Mother and Child Clinic Saint-Petersburg

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Evaluation of blood loss volume	At the end of the intervention
Secondary	Treatment characteristics	Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief	During 6 months since the intervention
Secondary	Impact on fertility	Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery	During 18 months since the intervention