Blood Loss, Surgical, Fertility Issues, Laparoscopic Myomectomy, Leiomyoma, Uterine, Myoma;Uterus, Postoperative Complications, Pregnancy Complications, Uterine Fibroid, Uterine Leiomyoma
Conditions
Keywords
temporary uterine artery occlusion, temporary uterine blood supply occlusion
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 leiomyoma.
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 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.
Interventions
PROCEDURELaparoscopic myomectomy with prior temporary uterine blood supply occlusion
Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
PROCEDUREConventional laparoscopic myomectomy
Laparoscopic myomectomy without prior temporary uterine blood supply occlusion
Sponsors
Mother and Child Clinic Saint-Petersburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | At the end of the intervention | Evaluation of blood loss volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment characteristics | During 6 months since the intervention | Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief |
| Impact on fertility | During 18 months since the intervention | Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery |
Countries
Russia
Contacts
Primary ContactAndrei Dubinin, MD, PhD
Backup ContactPavel Sorokin, MD
Outcome results
None listed