Myoma;UterusMYMOTE-1NCT03570879
Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.
An observational study of Myoma;Uterus, run by Università degli Studi dell'Insubria.
Trial summary
Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myoma;Uterus
- What is being tested?
- Power morcellation and Transvaginal extraction
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 May 2024
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.
Who may be able to join
- Women affected by single or multiple uterine myomas.
- Signed informed consent.
Who cannot join
- Human papilloma virus-related pathologies at pap-smear within the 12 months preceding surgery.
- Women with obliteration of the cul-de-sac.
- Women with the suspected cancer of gynecological origin.
- Women who had never experienced complete sexual intercourse before the operation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of Surgical Outcomes in Women Undergoing Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens
Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy.
Despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. Among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments).
Read more
Unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery.
In addition, on 24 November 24 2014 the Food and Drug Administration updated a Safety Communication about Power Morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis.
Considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. In this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.
- Conditions
- Myoma;Uterus
- Being tested
- Power morcellation, Transvaginal extraction
- Keywords
- Laparoscopy, Power morcellation, Transvaginal extraction
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power morcellationDevice
Power morcellation of surgical specimens after laparoscopic myomectomy.
Transvaginal extractionProcedure or surgery
Transvaginal extraction of surgical specimens after laparoscopic myomectomy.
| Study group | Role | What they receive |
|---|---|---|
| Power morcellation | Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens. Receives: Device: Power morcellation | |
| Transvaginal extraction | Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens. Receives: Procedure: Transvaginal extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Number of surgical complications (Clavien-Dindo Classification)
Measured: Within 12 months after surgery.
Secondary outcomes (4)
Operative time
Duration of the surgery, expressed in minutes.
Measured: Through study completion, an average of 10 years (retrospective analysis)
Blood loss
Blood loss during the surgery, expressed in milliliters (ml).
Measured: Through study completion, an average of 10 years (retrospective analysis)
Hospital stay
Duration of the hospitalization, expressed in days
Measured: Through study completion, an average of 10 years (retrospective analysis)
Sexual function
Sexual function evaluated by Female Sexual Function Index questionnaire, investigating quantity and quality of sex [scale total score minimum: 2 (worse outcome), maximum: 36 (best outcome)]
Measured: 6 and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'InsubriaJvan Casarin, M.D., Principal investigator, Università degli Studi dell'InsubriaAntonella Cromi, M.D., Ph.D., Study chair, Università degli Studi dell'InsubriaFabio Ghezzi, M.D., Study director, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570879
- Sponsor's protocol ID
- MYMOTE-1
- Acronym
- MYMOTE-1
- Status last verified
- Sep 2021
- First submitted
- 30 May 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Surgical Outcomes in Women Undergoing Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens
- ClinicalTrials.gov ID
- NCT03570879
- Acronym / sponsor ID
- MYMOTE-1 / MYMOTE-1
- Conditions
- Myoma;Uterus
- Keywords
- Laparoscopy, Power morcellation, Transvaginal extraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Jun 2018 (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.
Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy.
Despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. Among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments).
Unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery.
In addition, on 24 November 24 2014 the Food and Drug Administration updated a Safety Communication about Power Morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis.
Considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. In this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power morcellation | – | Device: Power morcellationWomen that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens. |
| Transvaginal extraction | – | Procedure: Transvaginal extractionWomen that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.
Key inclusion criteria (2 listed)
- Women affected by single or multiple uterine myomas.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Human papilloma virus-related pathologies at pap-smear within the 12 months preceding surgery.
- Women with obliteration of the cul-de-sac.
- Women with the suspected cancer of gynecological origin.
- Women who had never experienced complete sexual intercourse before the operation.
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 |
|---|---|---|
| Power morcellationPower morcellation of surgical specimens after laparoscopic myomectomy. | Device | Power morcellation |
| Transvaginal extractionTransvaginal extraction of surgical specimens after laparoscopic myomectomy. | Procedure or surgery | Transvaginal extraction |
Primary outcome
Complication rate
Time frame: Within 12 months after surgery.
Number of surgical complications (Clavien-Dindo Classification)
4 secondary outcomes
Operative time
Time frame: Through study completion, an average of 10 years (retrospective analysis)
Blood loss
Time frame: Through study completion, an average of 10 years (retrospective analysis)
Hospital stay
Time frame: Through study completion, an average of 10 years (retrospective analysis)
Sexual function
Time frame: 6 and 12 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Simone Laganà, M.D. principal investigator
Università degli Studi dell'Insubria
Jvan Casarin, M.D. principal investigator
Università degli Studi dell'Insubria
Antonella Cromi, M.D., Ph.D. study chair
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
An observational study of Myoma;Uterus, run by Università degli Studi dell'Insubria.
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 2 inclusion and 4 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 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Antonio Simone Laganà, M.D. (+393296279579, antoniosimone.lagana@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: Within 12 months after surgery.). 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 30 Sep 2021.