Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy (OUTSET-1)

Università degli Studi dell'Insubria

Status: Unknown

Conditions: Pregnancy Complications; Delivery;Abnormal;Stillbirth

Treatments: Procedure: Transvaginal specimen extraction

Study type: Observational

Funder types: Other

Identifiers

NCT03439956

OUTSET-1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnancy

Exclusion criteria

• Any pre-existent cause of high risk for adverse obstetric outcomes.

Trial design

200 participants in 2 patient groups

Transvaginal specimen extraction (cases)

Description:

Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.

Treatment:

Procedure: Transvaginal specimen extraction

Controls

Description:

Pregnant women that did not undergo previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.