Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Myoma;Uterus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Power morcellation

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

Power morcellation

Intervention Type DEVICE

Power morcellation of surgical specimens after laparoscopic myomectomy.

Transvaginal extraction

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

Transvaginal extraction

Intervention Type PROCEDURE

Transvaginal extraction of surgical specimens after laparoscopic myomectomy.

Interventions

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Power morcellation

Power morcellation of surgical specimens after laparoscopic myomectomy.

Intervention Type DEVICE

Transvaginal extraction

Transvaginal extraction of surgical specimens after laparoscopic myomectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No