Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 10:17 AM
Study NCT ID:
NCT07317635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Implementing a National Classification of Surgical Emergencies on Postoperative Morbidity and Mortality: a Prospective Multicenter Observational Study After Implementation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morbidity and mortality', 'timeFrame': 'At Day 30after surgery', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Emergencies']}, 'descriptionModule': {'briefSummary': '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.\n\nThe goal is to integrate this classification with a cognitive aid to improve patient triage and reduce waiting times for emergency surgery.\n\nThis classification will be presented at the 2026 SFAR Congress and as a practical decision-making tool.\n\nA 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).\n\nThe study will include 2500 patients over two-week periods between February and June 2027.\n\nExpected benefits include reduced patient morbidity and hospital stay, along with better emergency surgery planning and standardization across healthcare centers.', 'detailedDescription': '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.\n\nMain 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.\n\nMethods 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.\n\nExpected outcomes and benefits of the study results for patients, public health, and public policy decisions.\n\nFor 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.\n\nFor public health, the study will:\n\n* document the organizational impact of national standardization;\n* reduce inter-center variability;\n* limit nighttime surgery;\n* improve emergency surgical planning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults under legal protection (guardianship, curatorship, or judicial safeguard)\n\nPatients who object to the reuse of their personal data for research purposes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nPatient managed in a University Hospital (Centre Hospitalo-Universitaire) or General Hospital (Centre Hospitalier Général).\n\nPatients must receive initial management and diagnosis in the emergency department of the investigating center.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07317635', 'acronym': 'CLASSES', 'briefTitle': 'Impact of Implementing a National Classification of Surgical Emergencies on Postoperative Morbidity and Mortality: a Prospective Multicenter Observational Study After Implementation.', 'organization': {'class': 'OTHER', 'fullName': "Société Française d'Anesthésie et de Réanimation"}, 'officialTitle': 'Impact of Implementing a National Classification of Surgical Emergencies on Postoperative Morbidity and Mortality: a Prospective Multicenter Observational Study After Implementation.', 'orgStudyIdInfo': {'id': '2025-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before integration of classification of surgical emergencies', 'description': 'Before integration of classification of surgical emergencies'}, {'label': 'After integration of classification of surgical emergencies', 'description': 'After integration of a classification of surgical emergencies with a cognitive aid', 'interventionNames': ['Other: Implementation of classification of surgical emergencies']}], 'interventions': [{'name': 'Implementation of classification of surgical emergencies', 'type': 'OTHER', 'description': 'Observation of practices prior and after implementation of classification of surgical emergencies', 'armGroupLabels': ['After integration of classification of surgical emergencies']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'contacts': [{'name': 'Stephane Bar, MD', 'role': 'CONTACT'}], 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Stephane BAR, MD', 'role': 'CONTACT', 'email': 'Bar.Stéphane@chu-amiens.fr', 'phone': '+333.22.08.79.06'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Société Française d'Anesthésie et de Réanimation", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}