NCT03570879

Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Power morcellation	Power morcellation of surgical specimens after laparoscopic myomectomy.
PROCEDURE	Transvaginal extraction	Transvaginal extraction of surgical specimens after laparoscopic myomectomy.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2024-05-01
• First posted: 2018-06-27
• Last updated: 2021-09-30

Regulatory

• FDA-regulated device study