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

July 12, 2021 updated by: Andrey Dubinin, MD, PhD, Mother and Child Clinic Saint-Petersburg

ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrei Dubinin, MD, PhD
  • Phone Number: +79811506112
  • Email: andub@mail.ru

Study Contact Backup

  • Name: Pavel Sorokin, MD
  • Phone Number: +79835218691
  • Email: sor-pavel@ya.ru

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation, 199106
        • Recruiting
        • Mother and Child Clinic Saint-Petersburg
        • Contact:
          • Andrei Dubinin, MD, PhD
          • Phone Number: +79811506112
          • Email: andub@mail.ru
        • Principal Investigator:
          • Andrei Dubinin, MD, PhD
        • Sub-Investigator:
          • Pavel Sorokin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic myomectomy with temporary blood supply occlusion
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
Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
Other Names:
  • Temporary uterine arteries occlusion
Active Comparator: Conventional laparoscopic myomectomy
Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.
Procedure: Conventional laparoscopic myomectomy
Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: At the end of the intervention
Evaluation of blood loss volume
At the end of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment characteristics
Time Frame: During 6 months since the intervention
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
Impact on fertility
Time Frame: During 18 months since the intervention
Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery
During 18 months since the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mother and Child Clinic Saint-Petersburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2020

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCCSPb-8-12-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Clinical Trials on Laparoscopic myomectomy with prior temporary uterine blood supply occlusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe