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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Power morcellation | Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens. |
| |
| Transvaginal extraction | Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Power morcellation | Device | Power morcellation of surgical specimens after laparoscopic myomectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Number of surgical complications (Clavien-Dindo Classification) | Within 12 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Duration of the surgery, expressed in minutes. | Through study completion, an average of 10 years (retrospective analysis) |
| Blood loss | Blood loss during the surgery, expressed in milliliters (ml). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Simone Laganà, M.D. | Contact | +393296279579 | antoniosimone.lagana@asst-settelaghi.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Simone Laganà, M.D. | Università degli Studi dell'Insubria | Principal Investigator |
| Jvan Casarin, M.D. | Università degli Studi dell'Insubria | Principal Investigator |
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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Transvaginal extraction | Procedure | Transvaginal extraction of surgical specimens after laparoscopic myomectomy. |
|
| Through study completion, an average of 10 years (retrospective analysis) |
| Hospital stay | Duration of the hospitalization, expressed in days | 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)] | 6 and 12 months after surgery. |
| Antonella Cromi, M.D., Ph.D. |
| Università degli Studi dell'Insubria |
| Study Chair |
| Fabio Ghezzi, M.D. | Università degli Studi dell'Insubria | Study Director |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |