Clinical trial NCT04519593: ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Official title: ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Leiomyoma
Uterine Fibroid
Leiomyoma, Uterine
Myoma;Uterus
Laparoscopic Myomectomy
Postoperative Complications
Blood Loss, Surgical
Fertility Issues
Pregnancy Complications
Keywords: temporary uterine artery occlusion
temporary uterine blood supply occlusion
Lead sponsor: Mother and Child Clinic Saint-Petersburg
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood loss
timeFrame: At the end of the intervention
Secondary outcomes:
measure: Treatment characteristics
timeFrame: During 6 months since the intervention
measure: Impact on fertility
timeFrame: During 18 months since the intervention
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Mother and Child Clinic Saint-Petersburg
Study officials:
References: