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.
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
Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
Participation in an interventional Trial with an investigational medicinal product (IMP) or device
Patient refusal to participate in the Trial
Parallel
Temporary clipping of the uterine arteries and the utero-ovarian ligmants.
Procedure/SurgeryTemporary 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.
Procedure/SurgeryRobotically assisted myomectomy, for which no temporary clipping of the uterine arteries and the utero-ovarian ligaments
Peri-operative blood loss: Estimated blood loss
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
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
Multiple primary endpoints will be used to asses the blood loss: \- Need for peri-operative blood transfusion
Hospitalisation time
Number of postoperative nights the patient had to stay in the hospital.
Operation time in minutes
Total surgical time, from the completion of anesthesia induction untill the end of surgery (in minutes)
Number of patients with complications postoperatively, graded by Clavien Dindo classification
The Clavien Dindo classification is a validated tool to quantitatively assess postoperative complications. Grade 0: No complications Grade 1: Any deviation from normal postoperative course, without requiring intervention Grade 2: Requiring pharmacological treatment Grade 3: Requiring surgical, endoscopic or radiological intervention Grade 4: Life-treathening complication requiring intermediate or intensive care Grade 5: Death of a patient
Number of patients requiring secondary hemostatic measures
Was there a need for non-routine hemostatic measures, such as: * Tranexamic acid * Misoprostol * Oxytocin * Embolisation * Local application of sealant patch or glue (e.g TachoSil or Tisseel) * Hysterectomy
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Amsterdam UMC, location VUmc
Collaborator
Bichat Hospital
Collaborator
Rennes University Hospital
Collaborator
