ClinicalTrials.Veeva

Menu

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

U

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.

Trial contacts and locations

0

Loading...

Central trial contact

Antonio Simone Laganà, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems