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Temporary artery clipping during robot-assisted surgery to remove uterine fibroids

Tests temporarily clipping uterine arteries to limit bleeding in robot-assisted fibroid removal.

Key facts

Who runs it
Universitaire Ziekenhuizen KU Leuven
Where
Belgium, France, and Netherlands4 sites in 3 countriesChoose a country to see its sites
Trial code
Registry title
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Status
Recruiting
People taking part
82 people, planned
Started
4 May 2023
Planned end
30 May 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Temporary clipping of the uterine arteries and the utero-ovarian ligmants.
  • No temporary clipping of the uterine arteries and the utero-ovarian ligmants.
Record updated
14 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18-50 years with uterine fibroids (myomas) who can have surgery to remove them. It compares robot-assisted fibroid removal with or without temporary clipping of the arteries that feed the uterus.

Age
18-50 years
Sex
Women only
Disease stage
Uterine fibroids that can be removed by surgery. Fibroids of type FIGO 7-8 cannot be included.
Earlier treatment
People who had earlier or current treatments that could affect their safety or the trial cannot join.

Main reasons for not taking part

  • Cancer, or a possible cancer
  • Any reason they cannot have keyhole (laparoscopic) or robotic surgery
  • Taking part in another trial of a test drug or device
  • Any condition that the doctor thinks could affect safety or following the trial plan
  • Not using a highly effective birth control method

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Participants eligible for inclusion in this Trial must meet all of the following criteria:
  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner
  • Female
  • Age: 18-50 years
  • Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas

Who cannot take part

  • Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
  • any contra indication for a laparoscopic or robotic surgery
  • Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
  • (Possible) malignancy
  • Participants eligible for this Trial must not meet any of the following criteria:
  • Participation in an interventional Trial with an investigational medicinal product (IMP) or device
  • Patient refusal to participate in the Trial

This trial has no sites in United States.

It has sites in 3 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time.

The 2 groups in the trial

  • Temporary artery clippingTreatment being tested

    Patients undergoing a robotically-assisted myomectomies, with temporary clipping of the uterine arteries and the utero-ovarian ligmants.

    Treatment: Temporary clipping of the uterine arteries and the utero-ovarian ligmants.

  • ControlExisting treatment, for comparison

    Patients undergoing a robotically-assisted myomectomies, without temporary clipping of the uterine arteries and the utero-ovarian ligmants.

    Treatment: No temporary clipping of the uterine arteries and the utero-ovarian ligmants.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Plain-language title
Temporary artery clipping during robot-assisted surgery to remove uterine fibroidsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
14 March 2025