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Trial record 2 of 640 for:    transvaginal

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
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

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.


Condition or disease Intervention/treatment
Pregnancy Complications Delivery;Abnormal;Stillbirth Procedure: Transvaginal specimen extraction

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.

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



Primary Outcome Measures :
  1. Cesarean sections [ Time Frame: During the whole study period (2 years). ]
    Percentage of cesarean sections


Secondary Outcome Measures :
  1. Operative deliveries [ Time Frame: During the whole study period (2 years). ]
    Percentage of operative deliveries

  2. Gestational age at deliveries [ Time Frame: During the whole study period (2 years). ]
    Gestational age at the moment of delivery.

  3. Pregnancy complications [ Time Frame: During the whole study period (2 years). ]
    Percentages of complications occurring during pregnancies.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
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.
Criteria

Inclusion Criteria:

  • Pregnancy

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Antonio Simone Laganà, M.D. 3296279579 ext +39 antoniosimone.lagana@asst-settelaghi.it

Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Antonio Simone Laganà, M.D. Università degli Studi dell'Insubria

Responsible Party: Antonio Simone Laganà, Medical Doctor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03439956     History of Changes
Other Study ID Numbers: OUTSET-1
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Obstetric outcomes
Transvaginal specimen extraction
Gynecological laparoscopy

Additional relevant MeSH terms:
Pregnancy Complications
Stillbirth
Fetal Death
Death
Pathologic Processes