Temporary artery clipping during robot-assisted myomectomy for fibroids

Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial

This study is testing if temporarily clipping certain blood vessels during robot-assisted surgery for fibroids can help reduce bleeding and improve recovery for women undergoing the procedure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 4 sites (Leuven and 3 other locations)
• Trial ID: NCT06269809 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-50 with myomas eligible for myomectomy, excluding certain high-grade myomas.

Not a fit: Patients with disorders that may jeopardize their participation or those with FIGO 7-8 myomas will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce blood loss and improve recovery outcomes for patients undergoing myomectomy.

How similar studies have performed: While temporary artery clipping has shown promise in conventional laparoscopy, its application in robotically assisted myomectomy is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Leuven and 3 other locations

• 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

Conditions: Fibroid Uterus, myomectomy, fibroid, myoma, blood loss, temporary artery clipping, hemostatic measures