Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy (OUTSET-1)
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|ClinicalTrials.gov Identifier: NCT03439956|
Recruitment Status : Not yet recruiting
First Posted : February 20, 2018
Last Update Posted : February 22, 2018
One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal contamination of potentially infected or malignant tissues. Possibilities for specimen extraction during laparoscopy include minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal extraction through posterior colpotomy.
Although recent evidence has already suggested that transvaginal extraction through posterior colpotomy is a safe and feasible option, to date there are no published data about obstetric outcomes after this procedure.
For this reason, the current study aims to evaluate obstetric outcomes between women that underwent transvaginal specimen extraction through posterior colpotomy and women who did not.
|Condition or disease||Intervention/treatment|
|Pregnancy Complications Delivery;Abnormal;Stillbirth||Procedure: Transvaginal specimen extraction|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Evaluation of Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy|
|Estimated Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||April 1, 2021|
Transvaginal specimen extraction (cases)
Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.
Procedure: Transvaginal specimen extraction
Previous transvaginal specimen extraction through posterior colpotomy.
Pregnant women that did not undergo previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.
- Cesarean sections [ Time Frame: During the whole study period (2 years). ]Percentage of cesarean sections
- Operative deliveries [ Time Frame: During the whole study period (2 years). ]Percentage of operative deliveries
- Gestational age at deliveries [ Time Frame: During the whole study period (2 years). ]Gestational age at the moment of delivery.
- Pregnancy complications [ Time Frame: During the whole study period (2 years). ]Percentages of complications occurring during pregnancies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439956
|Contact: Antonio Simone Laganà, M.D.||3296279579 ext +firstname.lastname@example.org|
|Principal Investigator:||Antonio Simone Laganà, M.D.||Università degli Studi dell'Insubria|