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NCT05858554 Clinical Trial

The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg

Laparoscopy Clinical Trial

— Coelios  

Official title:
The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05858554
Other study ID # 8952
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 19, 2023
Est. completion date December 19, 2023

Study information
Verified date May 2023
Source University Hospital, Strasbourg, France
Contact Victor GABRIELE, MD
Phone 33 3 69 55 34 04
Email victor.gabriele@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Veress techniques and open laparoscopy are the techniques most used by gynecological surgeons to date. Advantages of the direct introduction unknown because technique still little used. The research hypothesis is that very few major complications are expected showing the safety of direct introduction. A look back at the practice of direct introduction into laparoscopy from 2012 to 2022 at the CMCO (Medical-Surgical and Obstetrical Center of Strasbourg)

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 19, 2023
Est. primary completion date December 19, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria: - Adult woman who had a scheduled or emergency laparoscopy at the CMCO between 01/01/2010 and 12/31/2022. - Subject, having not expressed their opposition to the reuse of data of their data for the purposes of scientific research. Exclusion criteria: - Subject having expressed its opposition to the reuse of its data for scientific res

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Gynécologie Obstétrique - CHU de Strasbourg - France Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study of intraoperative complications of direct introduction in open laparoscopy Files analysed retrospectively from from January 01, 2010 to December 31, 2022 will be examined
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