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

NCT04519593 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-14

No results posted yet for this 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.

Conditions

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

Interventions

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.

PROCEDURE

Conventional laparoscopic myomectomy

Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

Sponsors & Collaborators

  • Mother and Child Clinic Saint-Petersburg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-27
Primary Completion
2022-08-31
Completion
2022-11-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519593 on ClinicalTrials.gov