Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens. (MYMOTE-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03570879|
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
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|
|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|
Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.
Device: Power morcellation
Power morcellation of surgical specimens after laparoscopic myomectomy.
Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.
Procedure: Transvaginal extraction
Transvaginal extraction of surgical specimens after laparoscopic myomectomy.
- Complication rate [ Time Frame: Within 12 months after surgery. ]Number of surgical complications (Clavien-Dindo Classification)
- Operative time [ Time Frame: Through study completion, an average of 10 years (retrospective analysis) ]Duration of the surgery, expressed in minutes.
- Blood loss [ Time Frame: Through study completion, an average of 10 years (retrospective analysis) ]Blood loss during the surgery, expressed in milliliters (ml).
- Hospital stay [ Time Frame: Through study completion, an average of 10 years (retrospective analysis) ]Duration of the hospitalization, expressed in days
- 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)]
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
|Contact: Antonio Simone Laganà, M.D.||+email@example.com|
|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|