ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients Wi… (NCT04519593) | Clinical Trial Compass
UnknownNot Applicable
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Russia120 participantsStarted 2020-09-27
Plain-language summary
A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic uterine leiomyoma
* Size of leiomyoma node \>5 cm based on imaging
* Leiomyoma node types 3, 4, 5, 6 according to The International Federation of Gynecology and Obstetrics (FIGO) classification or type 2 not feasible to be removed during hysteroscopy
* Single or multiple nodes
* Absent contraindications for laparoscopic myomectomy
* Voluntarily signed informed consent to participate in the study
Exclusion Criteria:
* Age \< 18 years
* Asymptomatic uterine leiomyoma
* Size of leiomyoma node \<5 cm based on imaging
* Absence of leiomyoma node types 3, 4, 5, 6 according to FIGO classification and type 2 not feasible to be removed during hysteroscopy
* Planned simultaneous hysteroscopy with leiomyoma node excision
* Current pregnancy and breastfeeding
* Suspicion of a malignant uterine tumor
* Prior uterine leiomyoma surgery
* Contraindications for laparoscopic myomectomy
* Lack of decision-making capacity hindering signing the consent to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.