- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05836727
Use of Laparoscopy in the Treatment of Pelvic Ring Ruptures (PELVICOELIO)
April 28, 2023 updated by: University Hospital, Brest
Case series to describe the use of laparoscopy for the treatment of pelvic ring disruption.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brest, France, 29609
- Chu Brest
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-
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
No
Sampling Method
Non-Probability Sample
Study Population
patients who underwent laparoscopy for the treatment of pelvic ring disruption
Description
Inclusion Criteria:
- patients who underwent laparoscopy for the treatment of pelvic ring disruption
Exclusion Criteria:
- patient < 18 years old
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 |
Measure Description |
Time Frame |
|---|---|---|
|
conversion rate to open surgery
Time Frame: intraoperative
|
conversion rate to open surgery
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2023
Primary Completion (Actual)
April 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
April 19, 2023
First Submitted That Met QC Criteria
April 28, 2023
First Posted (Actual)
May 1, 2023
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC23.0010 - PELVICOELIO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH.
Requestors will be required to sign and complete a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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