Status:
UNKNOWN
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Lead Sponsor:
Mother and Child Clinic Saint-Petersburg
Conditions:
Uterine Leiomyoma
Uterine Fibroid
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 le...
Detailed Description
Primary endpoints • Assess the volume of blood loss Secondary endpoints * Compare the rates of intra- and postoperative complications, the necessity of blood transfusion, length of surgery, length ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04519593
Start Date
September 27 2020
End Date
November 1 2022
Last Update
July 14 2021
Active Locations (1)
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1
Mother and Child Clinic Saint-Petersburg
Saint Petersburg, Russia, 199106