Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

• Conditions: Myoma;Uterus
• Interventions: Device: Power morcellation; Procedure: Transvaginal extraction

• Registration Number: NCT03570879
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30
• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Power morcellation	Power morcellation	Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.
Transvaginal extraction	Transvaginal extraction	Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.

Primary Outcome Measures

Name	Time	Method
Complication rate	Within 12 months after surgery.	Number of surgical complications (Clavien-Dindo Classification)

Secondary Outcome Measures

Name	Time	Method
Operative time	Through study completion, an average of 10 years (retrospective analysis)	Duration of the surgery, expressed in minutes.
Blood loss	Through study completion, an average of 10 years (retrospective analysis)	Blood loss during the surgery, expressed in milliliters (ml).
Hospital stay	Through study completion, an average of 10 years (retrospective analysis)	Duration of the hospitalization, expressed in days
Sexual function	6 and 12 months after surgery.	Sexual function evaluated by Female Sexual Function Index questionnaire, investigating quantity and quality of sex \[scale total score minimum: 2 (worse outcome), maximum: 36 (best outcome)\]