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NCT05271877 Clinical Trial

Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy

Pregnancy Related Clinical Trial

Official title:
Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05271877
Other study ID # LAPRE-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2022
Est. completion date December 2024

Study information
Verified date February 2022
Source Università degli Studi dell'Insubria
Contact Antonio Simone Laganà, M.D., Ph.D.
Phone 3296279579
Email antoniosimone.lagana@uninsubria.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Laparoscopy, when applicable, is the current gold standard management for abdominal and pelvic surgery. Although accumulating evidence suggests that laparoscopy is associated with reduced intraoperative and postoperative morbidity, reduced hospital stay, better recovery and cosmesis compared with open surgery (laparotomy), the use of this technique in pregnant women is still debated. Considering this point, we aimed to collect retrospectively cases of laparoscopic surgery during pregnancy, regardless of the indication and gestational age, in order to analyze both surgical and obstetric outcomes during and after the procedure.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Pregnant women (regardless of gestational age) - At least one indication for laparoscopic surgery Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopy
Diagnostic/operative laparoscopic procedure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative complication Any complication during laparoscopy From the beginning to the end of laparoscopy
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