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Clinical Trials in France / NCT06269809
Recruiting Not applicable

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

NCT06269809 · tracked via the Priya Life Science France tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Not applicable
Started
2023-05-04
Last updated
2025-03-14

Condition(s) studied

Fibroid Uterus

Investigational drug(s) / intervention(s)

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

Temporary clipping of the uterine arteries and the utero-ovarian ligmants.: Temporary clipping of the uterine arteries and the utero-ovarian ligaments using laparoscopic clips/bulldog clamps, during robotically assisted myomectomy.

No temporary clipping of the uterine arteries and the utero-ovarian ligmants.: Robotically assisted myomectomy, for which no temporary clipping of the uterine arteries and the utero-ovarian ligaments

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Peri-operative blood loss: Estimated blood loss — 1 week
    Multiple primary endpoints will be used to asses the blood loss: \- Estimated blood loss \>500 mL
  • Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL — 1 day
    Multiple primary endpoints will be used to asses the blood loss: \- Hemoglobin drop perioperatively \>2g/dL (difference between hemoglobin preoperatively and postoperatively)
  • Peri-operative blood loss: Need for peri-operative blood transfusion — 1 week
    Multiple primary endpoints will be used to asses the blood loss: \- Need for peri-operative blood transfusion

Trial sites (4)

FacilityCityRegionStatus
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

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AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT Active, not recruiting

Other trials for the same condition

Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings Recruiting
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06269809 on ClinicalTrials.gov ↗ ← All trials in France