ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
NCT ID: NCT04519593
Last Updated: 2021-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2020-09-27
2022-11-01
Brief Summary
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Detailed Description
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• 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 of hospital and ICU stay, and leiomyoma symptoms relief
* Determine the procedure impact on fertility by evaluating the level of anti-mullerian hormone, pregnancy rates, pregnancy complications, and the way of delivery
Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach.
Sixty patients will undergo laparoscopic myomectomy preceded by temporary uterine blood supply occlusion performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study. Sixty patients will undergo conventional laparoscopic myomectomy performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study.
Patients eligible for inclusion, after signing an informed voluntary consent to participate in the study, will be randomized in a 1:1 ratio to the treatment groups using stratification by age, size, and leiomyoma nodes location.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic myomectomy with temporary blood supply occlusion
Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
Laparoscopic myomectomy with prior temporary uterine blood supply occlusion
Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
Conventional laparoscopic myomectomy
Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.
Conventional laparoscopic myomectomy
Laparoscopic myomectomy without prior temporary uterine blood supply occlusion
Interventions
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Laparoscopic myomectomy with prior temporary uterine blood supply occlusion
Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
Conventional laparoscopic myomectomy
Laparoscopic myomectomy without prior temporary uterine blood supply occlusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Mother and Child Clinic Saint-Petersburg
OTHER
Responsible Party
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Andrey Dubinin, MD, PhD
Gynecologist
Locations
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Mother and Child Clinic Saint-Petersburg
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MCCSPb-8-12-2020
Identifier Type: -
Identifier Source: org_study_id
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