Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT04519593
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Sponsor:
Mother and Child Clinic Saint-Petersburg
Organization:
Study Overview
Official Title:
ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
• 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: