- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05888948
Surgical Emergencies Gradation and Postoperative Outcome (BUGRADA)
June 6, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Effect of Implementation of a Surgical Emergencies Gradation on Postoperative Outcome in Emergency Operating Theatre Patients of the Amiens-Picardy University Hospital
Reducing surgical waiting time has been shown to be associated with a reduction in postoperative morbidity and mortality in this type of surgery.
The use of a gradation of surgical emergencies makes it possible to prioritise them in an objective, consensual manner and to carry them out within a theoretical expected waiting time relative to the degree of urgency.
The investigators hypothesise that exceeding the theoretical expected waiting time relative to the degree of urgency defined by the gradation of surgical emergencies is associated with an increase in postoperative morbidity and mortality in emergency surgery.
The objective is to assess the impact on post-operative morbidity and mortality of waiting times exceeding the theoretical expected time by grading the surgical emergencies of patients undergoing emergency surgery.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
700
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
- Name: Stéphane BAR, MD
- Phone Number: 03 22 08 79 06
- Email: bar.stephane@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens-Picardie
-
Contact:
- Stephane BAR
- Phone Number: 03 22 08 79 06
- Email: bar.stephane@chu-amiens.fr
-
-
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 requiring non-cardiac emergency surgery at the Amiens-Picardie University Hospital will be included.
A posteriori grading will be performed according to an institutionally recognised gradation.
Each grade is subject to a theoretical maximum time for surgical management.
The surgical waiting time and the waiting time exceeding the theoretical expected time of the gradation will be analysed.
Description
Inclusion Criteria:
- age > 18 years old.
- Non-cardiac emergency surgery.
Exclusion Criteria:
- Minor patients
- Emergency cardiac surgery
- Patients under guardianship or curators
- Pregnant women
- Patients who object to their personal data being used in research
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 |
---|---|
Number Post-operative complications
Time Frame: 1 year
|
1 year
|
Mortality at 1 year
Time Frame: 1 year
|
1 year
|
Length of stay in intensive care unit
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 25, 2022
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
May 25, 2023
First Submitted That Met QC Criteria
May 25, 2023
First Posted (Actual)
June 5, 2023
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2022_843_0056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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