Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

NCT03570879 | Unknown DMC FDA Device

• 1 other identifier: MYMOTE-1
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myoma;Uterus

Keywords

Laparoscopy; Power morcellation; Transvaginal extraction

Outcome Measures

Primary Outcomes (1)

• Complication rate

  Number of surgical complications (Clavien-Dindo Classification)

  Within 12 months after surgery.

Secondary Outcomes (4)

• Operative time

  Through study completion, an average of 10 years (retrospective analysis)

• Blood loss

  Through study completion, an average of 10 years (retrospective analysis)

• Hospital stay

  Through study completion, an average of 10 years (retrospective analysis)

• Sexual function

  6 and 12 months after surgery.

Study Arms (2)

Power morcellation

Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.

Device: Power morcellation

Transvaginal extraction

Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.

Procedure: Transvaginal extraction

Interventions

Power morcellation DEVICE

Power morcellation of surgical specimens after laparoscopic myomectomy.

Power morcellation

Transvaginal extraction PROCEDURE

Transvaginal extraction of surgical specimens after laparoscopic myomectomy.

Transvaginal extraction

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women affected by single or multiple uterine myomas.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Jvan Casarin, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Antonella Cromi, M.D., Ph.D.

  Università degli Studi dell'Insubria

  STUDY CHAIR

• Fabio Ghezzi, M.D.

  Università degli Studi dell'Insubria

  STUDY DIRECTOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

+393296279579; antoniosimone.lagana@asst-settelaghi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 27, 2018
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: September 30, 2021

Record last verified: 2021-09