Uterine LeiomyomaNCT04519593
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
A study testing Laparoscopic myomectomy with prior temporary uterine blood supply occlusion and Conventional laparoscopic myomectomy in people with Uterine Leiomyoma and Uterine Fibroid, run by Mother and Child Clinic Saint-Petersburg at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Leiomyoma, Uterine Fibroid, Leiomyoma, Uterine
- What is being tested?
- Laparoscopic myomectomy with prior temporary uterine blood supply occlusion and Conventional laparoscopic myomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 27 Sep 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Mother and Child Clinic Saint-Petersburg
Saint Petersburg, 199106
Andrei Dubinin, MD, PhD, +79811506112, andub@mail.ru
Andrei Dubinin, MD, PhD
About this study
Official title: ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
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.
Read the 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.
- Conditions
- Uterine Leiomyoma, Uterine Fibroid, Leiomyoma, Uterine, Myoma;Uterus, Laparoscopic Myomectomy, Postoperative Complications
- Being tested
- Laparoscopic myomectomy with prior temporary uterine blood supply occlusion, Conventional laparoscopic myomectomy
- Keywords
- temporary uterine artery occlusion, temporary uterine blood supply occlusion
- Medical subject headings
- Myofibroma, Leiomyoma, Postoperative Complications, Blood Loss, Surgical, Infertility, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic myomectomy with prior temporary uterine blood supply occlusionProcedure or surgery
Also called Temporary uterine arteries occlusion
Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
Conventional laparoscopic myomectomyProcedure or surgery
Laparoscopic myomectomy without prior temporary uterine blood supply occlusion
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic myomectomy with temporary blood supply occlusion | Experimental | Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries. Receives: Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion |
| Conventional laparoscopic myomectomy | Active comparator | Laparoscopic myomectomy is performed without prior temporary blood supply occlusion. Receives: Procedure: Conventional laparoscopic myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Evaluation of blood loss volume
Measured: At the end of the intervention
Secondary outcomes (2)
Treatment characteristics
Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief
Measured: During 6 months since the intervention
Impact on fertility
Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery
Measured: During 18 months since the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start27 Sep 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mother and Child Clinic Saint-Petersburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrey Dubinin, MD, PhD, Mother and Child Clinic Saint-Petersburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519593
- Sponsor's protocol ID
- MCCSPb-8-12-2020
- Status last verified
- Jul 2021
- First submitted
- 17 Aug 2020
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
- ClinicalTrials.gov ID
- NCT04519593
- Acronym / sponsor ID
- MCCSPb-8-12-2020
- Conditions
- Uterine Leiomyoma, Uterine Fibroid, Leiomyoma, Uterine, Myoma;Uterus, Laparoscopic Myomectomy, Postoperative Complications
- Keywords
- temporary uterine artery occlusion, temporary uterine blood supply occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mother and Child Clinic Saint-PetersburgUniversity, hospital or other
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic myomectomy with temporary blood supply occlusion | Experimental | Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusionLaparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries. |
| Conventional laparoscopic myomectomy | Active comparator | Procedure: Conventional laparoscopic myomectomyLaparoscopic myomectomy is performed without prior temporary blood supply occlusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic myomectomy with prior temporary uterine blood supply occlusionAlso: Temporary uterine arteries occlusionVisualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries. | Procedure or surgery | Laparoscopic myomectomy with temporary blood supply occlusion |
| Conventional laparoscopic myomectomyLaparoscopic myomectomy without prior temporary uterine blood supply occlusion | Procedure or surgery | Conventional laparoscopic myomectomy |
Primary outcome
Blood loss
Time frame: At the end of the intervention
Evaluation of blood loss volume
2 secondary outcomes
Treatment characteristics
Time frame: During 6 months since the intervention
Impact on fertility
Time frame: During 18 months since the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic myomectomy with prior temporary uterine blood supply occlusion and Conventional laparoscopic myomectomy in people with Uterine Leiomyoma and Uterine Fibroid, run by Mother and Child Clinic Saint-Petersburg at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrei Dubinin, MD, PhD (+79811506112, andub@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: At the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.