Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

Myoma;Uterus Clinical Trial

— MYMOTE-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03570879
• Other study ID #: MYMOTE-1
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: +393296279579
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus

Intervention

Device:
• Power morcellation
Power morcellation of surgical specimens after laparoscopic myomectomy.

Procedure:
• Transvaginal extraction
Transvaginal extraction of surgical specimens after laparoscopic myomectomy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Number of surgical complications (Clavien-Dindo Classification)	Within 12 months after surgery.
Secondary	Operative time	Duration of the surgery, expressed in minutes.	Through study completion, an average of 10 years (retrospective analysis)
Secondary	Blood loss	Blood loss during the surgery, expressed in milliliters (ml).	Through study completion, an average of 10 years (retrospective analysis)
Secondary	Hospital stay	Duration of the hospitalization, expressed in days	Through study completion, an average of 10 years (retrospective analysis)
Secondary	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.