ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

• Sponsor: Mother and Child Clinic Saint-Petersburg (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04519593
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.1
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Leiomyoma; Uterine Fibroid; Leiomyoma, Uterine; Myoma;Uterus; Laparoscopic Myomectomy; Postoperative Complications; Blood Loss, Surgical; Fertility Issues; Pregnancy Complications	Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion; Procedure: Conventional laparoscopic myomectomy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
• Actual Study Start Date: Sep 27, 2020
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion; Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.; Other Names: Temporary uterine arteries occlusion
Active Comparator: Conventional laparoscopic myomectomy Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.	Procedure: Conventional laparoscopic myomectomy; Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

Outcome Measures

Primary Outcome Measures

1. Blood loss [At the end of the intervention]

   Evaluation of blood loss volume

Secondary Outcome Measures

1. 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

2. Impact on fertility [During 18 months since the intervention]

   Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mother and Child Clinic Saint-Petersburg	Saint Petersburg		Russian Federation	199106

Sponsors and Collaborators

• Mother and Child Clinic Saint-Petersburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrey Dubinin, MD, PhD, Gynecologist, Mother and Child Clinic Saint-Petersburg
• ClinicalTrials.gov Identifier: NCT04519593
• Other Study ID Numbers: MCCSPb-8-12-2020
• First Posted: Aug 19, 2020
• Last Update Posted: Jul 14, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrey Dubinin, MD, PhD, Gynecologist, Mother and Child Clinic Saint-Petersburg: temporary uterine artery occlusion; temporary uterine blood supply occlusion
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Pregnancy Complications; Infertility; Postoperative Complications; Blood Loss, Surgical

Study Results

No Results Posted as of Jul 14, 2021