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

Last updated: July 12, 2021
Sponsor: Mother and Child Clinic Saint-Petersburg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Uterine Fibroids

Uterine Disorders

Treatment

N/A

Clinical Study ID

NCT04519593
MCCSPb-8-12-2020
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ofGynecology and Obstetrics (FIGO) classification or type 2 not feasible to be removedduring hysteroscopy
  • Single or multiple nodes
  • Absent contraindications for laparoscopic myomectomy
  • Voluntarily signed informed consent to participate in the study

Exclusion

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 2not 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 thestudy

Study Design

Total Participants: 120
Study Start date:
September 27, 2020
Estimated Completion Date:
November 01, 2022

Study 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.

Connect with a study center

  • Mother and Child Clinic Saint-Petersburg

    Saint Petersburg, 199106
    Russian Federation

    Active - Recruiting

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