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

NCT05858554 | Unknown

• 1 other identifier: 8952
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Laparoscopy

Keywords

Laparoscopy; coelioscopie; Veress Needle Technique

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Subject having expressed its opposition to the reuse of its data for scientific res

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gynécologie Obstétrique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Victor GABRIELE, MD

CONTACT

33 3 69 55 34 04; victor.gabriele@chru-strasbourg.fr

Juliana BALDASSARRE, MD

CONTACT

33 3 69 55 34 04; Juliana.baldassarre@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: April 19, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-05

Locations

FR (1)