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 range18 Years
SexFEMALE
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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