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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new technique to help control bleeding during a specific type of surgery called robotically-assisted myomectomy, which is used to remove fibroids (non-cancerous growths) from the uterus. The researchers want to see if temporarily clipping certain arteries during the surgery can reduce blood loss, the need for blood transfusions, and drops in hemoglobin levels (a measure of blood health). They will also look at how this technique affects surgery time and any complications that might arise.

To participate in this trial, women aged 18 to 50 with uterine fibroids that can be treated with myomectomy may qualify. Participants must agree to use effective birth control methods and give their written consent to join the study. If chosen, you can expect to undergo the surgery with the temporary artery clipping technique while being closely monitored for any effects. It's important to note that individuals with certain health conditions or previous treatments may not be eligible, as the safety of all participants is the top priority.

Gender

FEMALE

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