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

September 28, 2021 updated by: Antonio Simone Laganà, Università degli Studi dell'Insubria

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

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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.

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