Clinical trial NCT03570879: Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.
Official title: Analysis of Surgical Outcomes in Women Undergoing Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myoma;Uterus
Keywords: Laparoscopy
Power morcellation
Transvaginal extraction
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Complication rate
timeFrame: Within 12 months after surgery.
Secondary outcomes:
measure: Operative time
timeFrame: Through study completion, an average of 10 years (retrospective analysis)
measure: Blood loss
timeFrame: Through study completion, an average of 10 years (retrospective analysis)
measure: Hospital stay
timeFrame: Through study completion, an average of 10 years (retrospective analysis)
measure: Sexual function
timeFrame: 6 and 12 months after surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Jvan Casarin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Antonella Cromi, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Università degli Studi dell'Insubria
name: Fabio Ghezzi, M.D.
role: STUDY_DIRECTOR
References: