- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317635
Impact of Implementing a National Classification of Surgical Emergencies on Postoperative Morbidity and Mortality: a Prospective Multicenter Observational Study After Implementation. (CLASSES)
The ACUTE committee of the French Society of Anesthesia and Intensive Care (SFAR), in consultation with surgical societies, has developed a national classification of surgical emergencies to define the ideal time to surgery for each indication.
The goal is to integrate this classification with a cognitive aid to improve patient triage and reduce waiting times for emergency surgery.
This classification will be presented at the 2026 SFAR Congress and as a practical decision-making tool.
A prospective, multicenter study will then evaluate its impact by measuring the rate of severe postoperative complications at 30 days using the Comprehensive Complication Index (CCI).
The study will include 2500 patients over two-week periods between February and June 2027.
Expected benefits include reduced patient morbidity and hospital stay, along with better emergency surgery planning and standardization across healthcare centers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The ACUTE committee of the French Society of Anesthesia and Intensive Care (SFAR) has developed a national classification of surgical emergencies in consultation with all surgical societies to specify the ideal time before surgery for each surgical indication. The aim is to integrate this classification with a cognitive aid to help patients consider these timeframes, based on the surgical indication, and various other factors in order to improve triage and thus reduce waiting times before emergency surgery. This classification will be presented at the 2026 SFAR Congress, as well as in the form of a cognitive aid.
Main objective To evaluate the rate of severe postoperative complications, measured using the Clavien-Dindo score and continuously expressed using the Comprehensive Complication Index (CCI), at 30 days post-surgery after implementation of the national classification of surgical emergencies.
Methods This is a prospective, observational, multicenter study. The data collection period will consist of two consecutive weeks chosen by the inclusion center within the interval between February 1, 2027, and June 30, 2027. 100 patients will be included during each period per center, for a total of 2500 patients.
Expected outcomes and benefits of the study results for patients, public health, and public policy decisions.
For patients, reducing waiting times for emergency surgery is likely to decrease morbidity and mortality, serious complications, and length of hospital stay, while increasing the number of days spent at home and limiting reoperations and rehospitalizations.
For public health, the study will:
- document the organizational impact of national standardization;
- reduce inter-center variability;
- limit nighttime surgery;
- improve emergency surgical planning.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stephane BAR, MD
- Phone Number: +333.22.08.79.06
- Email: Bar.Stéphane@chu-amiens.fr
Study Locations
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Amiens, France
- CHU Amiens-Picardie
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Contact:
- Stephane Bar, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Adults under legal protection (guardianship, curatorship, or judicial safeguard)
Patients who object to the reuse of their personal data for research purposes
Description
Inclusion Criteria:
- Adults (≥18 years) undergoing non-cardiac emergency surgery, defined as surgery with a preoperative anesthetic consultation performed less than 48 hours before the surgical procedure.
Patient managed in a University Hospital (Centre Hospitalo-Universitaire) or General Hospital (Centre Hospitalier Général).
Patients must receive initial management and diagnosis in the emergency department of the investigating center.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Before integration of classification of surgical emergencies
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After integration of classification of surgical emergencies
After integration of a classification of surgical emergencies with a cognitive aid
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Observation of practices prior and after implementation of classification of surgical emergencies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative morbidity and mortality
Time Frame: At Day 30after surgery
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Postoperative morbidity and mortality assessed using the Clavien-Dindo score and expressed on a continuous scale by the Comprehensive Complication Index (CCI) at 30 days (D30)Day 30
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At Day 30after surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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