Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy

Evaluation of Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03439956

Acronym

OUTSET-1

Enrollment

200

Registered

2018-02-20

Start date

2022-04-01

Completion date

2024-04-01

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery;Abnormal;Stillbirth, Pregnancy Complications

Keywords

Obstetric outcomes, Transvaginal specimen extraction, Gynecological laparoscopy

Brief summary

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.

Interventions

PROCEDURETransvaginal specimen extraction

Previous transvaginal specimen extraction through posterior colpotomy.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Inclusion criteria

* Pregnancy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Cesarean sections	During the whole study period (2 years).	Percentage of cesarean sections

Secondary

Measure	Time frame	Description
Operative deliveries	During the whole study period (2 years).	Percentage of operative deliveries
Gestational age at deliveries	During the whole study period (2 years).	Gestational age at the moment of delivery.
Pregnancy complications	During the whole study period (2 years).	Percentages of complications occurring during pregnancies.

Contacts

Primary ContactAntonio Simone Laganà, M.D.

antoniosimone.lagana@asst-settelaghi.it3296279579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026