An observational study in Myoma;Uterus, sponsored by Università degli Studi dell'Insubria. Status unknown. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by Università degli Studi dell'Insubria · Observational
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's planned enrollment of 250 is above the median of 150 across 119 observational studies indexed under Leiomyoma.
Browse Leiomyoma studies →Università degli Studi dell'Insubria is the lead sponsor of 67 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.
Device: Power morcellation
Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.
Procedure: Transvaginal extraction
Power morcellation of surgical specimens after laparoscopic myomectomy.
Transvaginal extraction of surgical specimens after laparoscopic myomectomy.
Complication rate
Number of surgical complications (Clavien-Dindo Classification)
Time frame: Within 12 months after surgery.
Operative time
Duration of the surgery, expressed in minutes.
Time frame: Through study completion, an average of 10 years (retrospective analysis)
Blood loss
Blood loss during the surgery, expressed in milliliters (ml).
Time frame: Through study completion, an average of 10 years (retrospective analysis)
Hospital stay
Duration of the hospitalization, expressed in days
Time frame: Through study completion, an average of 10 years (retrospective analysis)
Sexual function
Sexual function evaluated by Female Sexual Function Index questionnaire, investigating quantity and quality of sex \[scale total score minimum: 2 (worse outcome), maximum: 36 (best outcome)\]
Time frame: 6 and 12 months after surgery.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Insubria