Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

Study Overview
=================
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.

Official Title
-----------------
Analysis of Surgical Outcomes in Women Undergoing Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens

Conditions
-----------------
Myoma;Uterus

Intervention / Treatment
-----------------
* Device: Power morcellation
* Procedure: Transvaginal extraction


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Power morcellation<br>Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens. | Device: Power morcellation<br>* Power morcellation of surgical specimens after laparoscopic myomectomy.<br>|
| Transvaginal extraction<br>Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens. | Procedure: Transvaginal extraction<br>* Transvaginal extraction of surgical specimens after laparoscopic myomectomy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Number of surgical complications (Clavien-Dindo Classification) | Within 12 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Duration of the surgery, expressed in minutes. | Through study completion, an average of 10 years (retrospective analysis) | 
| Blood loss | Blood loss during the surgery, expressed in milliliters (ml). | Through study completion, an average of 10 years (retrospective analysis) | 
| Hospital stay | Duration of the hospitalization, expressed in days | Through study completion, an average of 10 years (retrospective analysis) | 
| Sexual function | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopy, Power morcellation, Transvaginal extraction