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Trial record 5 of 639 for:    transvaginal

Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens. (MYMOTE-1)

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ClinicalTrials.gov Identifier: NCT03570879
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

Brief 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.

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.


Condition or disease Intervention/treatment
Myoma;Uterus Device: Power morcellation Procedure: Transvaginal extraction

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Analysis of Surgical Outcomes in Women Undergoing Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Group/Cohort Intervention/treatment
Power morcellation
Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.
Device: Power morcellation
Power morcellation of surgical specimens after laparoscopic myomectomy.

Transvaginal extraction
Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.
Procedure: Transvaginal extraction
Transvaginal extraction of surgical specimens after laparoscopic myomectomy.




Primary Outcome Measures :
  1. Complication rate [ Time Frame: Within 12 months after surgery. ]
    Number of surgical complications (Clavien-Dindo Classification)


Secondary Outcome Measures :
  1. Operative time [ Time Frame: Through study completion, an average of 10 years (retrospective analysis) ]
    Duration of the surgery, expressed in minutes.

  2. Blood loss [ Time Frame: Through study completion, an average of 10 years (retrospective analysis) ]
    Blood loss during the surgery, expressed in milliliters (ml).

  3. Hospital stay [ Time Frame: Through study completion, an average of 10 years (retrospective analysis) ]
    Duration of the hospitalization, expressed in days

  4. 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)]



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570879


Contacts
Contact: Antonio Simone Laganà, M.D. +393296279579 antoniosimone.lagana@asst-settelaghi.it

Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Antonio Simone Laganà, M.D. Università degli Studi dell'Insubria
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

Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03570879     History of Changes
Other Study ID Numbers: MYMOTE-1
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Laparoscopy
Power morcellation
Transvaginal extraction

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases