- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570879
Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens. (MYMOTE-1)
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).
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women affected by single or multiple uterine myomas.
- Signed informed consent.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Power morcellation
Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.
|
Power morcellation of surgical specimens after laparoscopic myomectomy.
|
Transvaginal extraction
Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.
|
Transvaginal extraction of surgical specimens after laparoscopic myomectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complication rate
Time Frame: Within 12 months after surgery.
|
Number of surgical complications (Clavien-Dindo Classification)
|
Within 12 months after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time
Time Frame: Through study completion, an average of 10 years (retrospective analysis)
|
Duration of the surgery, expressed in minutes.
|
Through study completion, an average of 10 years (retrospective analysis)
|
Blood loss
Time Frame: Through study completion, an average of 10 years (retrospective analysis)
|
Blood loss during the surgery, expressed in milliliters (ml).
|
Through study completion, an average of 10 years (retrospective analysis)
|
Hospital stay
Time Frame: Through study completion, an average of 10 years (retrospective analysis)
|
Duration of the hospitalization, expressed in days
|
Through study completion, an average of 10 years (retrospective analysis)
|
Sexual function
Time Frame: 6 and 12 months after surgery.
|
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)]
|
6 and 12 months after surgery.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jvan Casarin, M.D., Università degli Studi dell'Insubria
- Study Chair: Antonella Cromi, M.D., Ph.D., Università degli Studi dell'Insubria
- Study Director: Fabio Ghezzi, M.D., Università degli Studi dell'Insubria
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MYMOTE-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myoma;Uterus
-
Yonsei UniversityCompleted
-
Yonsei UniversityCompletedMyoma of UterusKorea, Republic of
-
Immunitor LLCUnknownLeiomyoma | Fibroma | Myoma;Uterus | Fibroid UterusMongolia
-
Universitaire Ziekenhuizen KU LeuvenRecruitingUltrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology (MUSA1)Myoma;Uterus | Sarcoma UterusBelgium
-
University Hospital, Clermont-FerrandActive, not recruitingMyoma;Uterus | Adenomyoma of UterusFrance
-
University of CagliariAzienda Ospedaliera Ordine Mauriziano di Torino; University of Foggia; Civic... and other collaboratorsRecruiting
-
University Hospital, Clermont-FerrandRecruiting
-
Ciusss de L'Est de l'Île de MontréalCentre integre universitaire de sante et de services sociaux du Centre-Sud-de-l...Not yet recruitingMyoma;Uterus | Polyp UterusCanada
-
Seoul National University HospitalJeysis MedicalNot yet recruiting
-
Mansoura UniversityUnknown
Clinical Trials on Power morcellation
-
University Magna GraeciaCompleted
-
George Washington UniversityWithdrawn
-
Ege UniversityCompleted
-
University Hospital, Strasbourg, FranceCompletedEndometrial PolypsFrance
-
ARKSurgicalUnknown
-
Hospices Civils de LyonCompletedLaparoscopy | Uterine Myomatosis | Hysterectomy, VaginalFrance
-
National Taiwan University HospitalCompletedSurgical Procedure, UnspecifiedTaiwan
-
University of OklahomaU.S. Department of EducationCompletedCerebral Palsy | Child, PreschoolUnited States
-
I.M. Sechenov First Moscow State Medical UniversityUnknownBladder CancerRussian Federation
-
Youngstown State UniversityCompleted