NCT04519593

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 27, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

August 17, 2020

Last Update Submit

July 12, 2021

Conditions

Uterine LeiomyomaUterine FibroidLeiomyoma, UterineMyoma;UterusLaparoscopic MyomectomyPostoperative ComplicationsBlood Loss, SurgicalFertility IssuesPregnancy Complications

Keywords

temporary uterine artery occlusiontemporary uterine blood supply occlusion

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    Evaluation of blood loss volume

    At the end of the intervention

Secondary Outcomes (2)

  • Treatment characteristics

    During 6 months since the intervention

  • Impact on fertility

    During 18 months since the intervention

Study Arms (2)

Laparoscopic myomectomy with temporary blood supply occlusion

EXPERIMENTAL

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

Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion

Conventional laparoscopic myomectomy

ACTIVE COMPARATOR

Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.

Procedure: Conventional laparoscopic myomectomy

Interventions

Laparoscopic myomectomy with prior temporary uterine blood supply occlusionPROCEDURE

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

Also known as: Temporary uterine arteries occlusion
Laparoscopic myomectomy with temporary blood supply occlusion
Conventional laparoscopic myomectomyPROCEDURE

Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

Conventional laparoscopic myomectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mother and Child Clinic Saint-Petersburg

Saint Petersburg, 199106, Russia

RECRUITING

MeSH Terms

Conditions

MyofibromaLeiomyomaPostoperative ComplicationsBlood Loss, SurgicalInfertilityPregnancy Complications

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesNeoplasms, Muscle TissuePathologic ProcessesPathological Conditions, Signs and SymptomsHemorrhageIntraoperative ComplicationsGenital DiseasesUrogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Andrei Dubinin, MD, PhD

CONTACT

+79811506112andub@mail.ru

Pavel Sorokin, MD

CONTACT

+79835218691sor-pavel@ya.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologist

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 19, 2020

Study Start

September 27, 2020

Primary Completion

August 31, 2022

Study Completion

November 1, 2022

Last Updated

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)