An interventional study of Laparoscopic myomectomy with prior temporary uterine blood supply occlusion and Conventional laparoscopic myomectomy in Uterine Leiomyoma, Uterine Fibroid and Leiomyoma, Uterine, sponsored by Mother and Child Clinic Saint-Petersburg. Status unknown at 1 site in Russian Federation. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Mother and Child Clinic Saint-Petersburg · Not applicable, Interventional, and Treatment
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.
Primary endpoints
Secondary endpoints
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →This is the only study on the registry with Mother and Child Clinic Saint-Petersburg as lead sponsor.
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Exclusion Criteria:
Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion
Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.
Procedure: Conventional laparoscopic myomectomy
Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
Also known as: Temporary uterine arteries occlusion
Laparoscopic myomectomy without prior temporary uterine blood supply occlusion
Blood loss
Evaluation of blood loss volume
Time frame: At the end of the intervention
Treatment characteristics
Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief
Time frame: During 6 months since the intervention
Impact on fertility
Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery
Time frame: During 18 months since the intervention
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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