Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy

NCT03439956 | Unknown DMC

• 1 other identifier: OUTSET-1
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Complications; Delivery;Abnormal;Stillbirth

Keywords

Obstetric outcomes; Transvaginal specimen extraction; Gynecological laparoscopy

Outcome Measures

Primary Outcomes (1)

• Cesarean sections

  Percentage of cesarean sections

  During the whole study period (2 years).

Secondary Outcomes (3)

• Operative deliveries

  During the whole study period (2 years).

• Gestational age at deliveries

  During the whole study period (2 years).

• Pregnancy complications

  During the whole study period (2 years).

Study Arms (2)

Transvaginal specimen extraction (cases)

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

Procedure: Transvaginal specimen extraction

Controls

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

Interventions

Transvaginal specimen extraction PROCEDURE

Previous transvaginal specimen extraction through posterior colpotomy.

Transvaginal specimen extraction (cases)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction (cases) and pregnant women that did not.

You may qualify if:

• Pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

3296279579; antoniosimone.lagana@asst-settelaghi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 20, 2018
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: September 30, 2021

Record last verified: 2021-09