Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Universitaire Ziekenhuizen KU Leuven
82 participants
May 4, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
Exclusion Criteria7
- Participants eligible for this Trial must not meet any of the following criteria:
- 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
- (Possible) malignancy
- any contra indication for a laparoscopic or robotic surgery
Interventions
Temporary clipping of the uterine arteries and the utero-ovarian ligaments using laparoscopic clips/bulldog clamps, during robotically assisted myomectomy.
Robotically assisted myomectomy, for which no temporary clipping of the uterine arteries and the utero-ovarian ligaments
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06269809