Temporary artery clipping during robot-assisted myomectomy for fibroids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of temporarily clipping the uterine artery and utero-ovarian ligament during robotically assisted myomectomy for uterine fibroids. The study aims to compare outcomes such as estimated blood loss, need for transfusion, and hemoglobin drop between patients receiving the clipping intervention and those who do not. By focusing on these primary endpoints, the trial also evaluates secondary outcomes like complication rates and operation time. The goal is to improve surgical outcomes and reduce bleeding complications associated with myomectomy procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants eligible for inclusion in this Trial must meet all of the following criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. 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.
3. Female
4. Age: 18-50 years
5. Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas.

Exclusion Criteria:

Participants eligible for this Trial must not meet any of the following criteria:

1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
3. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
4. Patient refusal to participate in the Trial
5. (Possible) malignancy
6. any contra indication for a laparoscopic or robotic surgery

Where it's running

• University Hospitals Leuven
  Leuven, Belgium Recruiting
• Department of Gynecology and Obstetrics, Hopital Bichat
  Paris, France Not yet recruiting
• Service de gynécologie, Centre Hospitalier Universitaire de Rennes
  Rennes, France Not yet recruiting
• Amsterdam UMC, locatie VUmc
  Amsterdam, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Wouter Froyman, MD, PhD — Universitaire Ziekenhuizen KU Leuven
• Study coordinator: Stefan Timmerman, MD
• Email: stefan.timmerman@uzleuven.be
• Phone: +3216348826

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.