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

October 30, 2023 updated by: University Hospital, Strasbourg, France

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)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Gynécologie Obstétrique - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Victor Gabriele, MD
        • Principal Investigator:
          • Juliana BALDASSARRE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult woman who had a scheduled or emergency laparoscopy at the CMCO between 01/01/2010 and 12/31/2022.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study of intraoperative complications of direct introduction in open laparoscopy
Time Frame: Files analysed retrospectively from from January 01, 2010 to December 31, 2022 will be examined
Files analysed retrospectively from from January 01, 2010 to December 31, 2022 will be examined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Estimated)

December 19, 2023

Study Completion (Estimated)

December 19, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8952

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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