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

Università degli Studi dell'Insubria

Status

Unknown

Conditions

Myoma;Uterus

Treatments

Device: Power morcellation

Procedure: Transvaginal extraction

Study type

Observational

Funder types

Other

Identifiers

NCT03570879

MYMOTE-1

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.