Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT03643718
Status:
RECRUITING
Last Update Posted:
2020-07-14
First Post:
2018-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-based International Register of Emergency Surgery and Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D005547', 'term': 'Foreign Bodies'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients treated with surgery', 'timeFrame': 'Until hospital discharge, approximately 2 weeks', 'description': 'Evaluate the rate of operative treatment for each different disease according to the different enviroment; for each intervention the surgical approach (laparotomic, mini-invasive, laparoscopic) will be evaluated.'}, {'measure': 'Rate of patients treated with conservative treatment', 'timeFrame': 'Until hospital discharge, approximately 2 weeks', 'description': "Evaluate the conservative treatment rate for each different disease according to patient's characteristics and the enviroinment."}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Until hospital discharge, approximately 2 weeks', 'description': 'To evaluate the differences in mortality rate linked to the different managements, techniques, environments and patient variables.'}, {'measure': 'Morbidity', 'timeFrame': 'Until hospital discharge, approximately 2 weeks', 'description': 'To evaluate the differences in morbidity rate linked to the different managements, techniques, environments and patient variables.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Appendicitis', 'Acute Cholecystitis', 'Acute Diverticulitis', 'Post-operative Complications', 'Acute Pancreatitis', 'Perforated Gastro-duodenal Ulcers', 'Adhesive Small Bowell Occlusion', 'Colonic Neoplastic Emergencies', 'Gynecological Emergencies', 'Vascular Emergencies', 'Intestinal Ischemia', 'Abdominal Wall Hernia', 'Foreign Bodies', 'Caustic Ingestion', 'Trauma']}, 'referencesModule': {'references': [{'pmid': '37160552', 'type': 'DERIVED', 'citation': 'Coccolini F, Mazzoni A, Cremonini C, Cobuccio L, Pucciarelli M, Vetere G, Borelli B, Strambi S, Musetti S, Miccoli M, Cremolini C; WIRES-T Study Group; Tartaglia D, Chiarugi M. Colorectal neoplastic emergencies in immunocompromised patients: preliminary result from the Web-based International Register of Emergency Surgery and Trauma (WIRES-T trial). Updates Surg. 2023 Sep;75(6):1579-1587. doi: 10.1007/s13304-023-01521-8. Epub 2023 May 9.'}]}, 'descriptionModule': {'briefSummary': 'The WIRES-T project (Web-based International Registry of Emergency General Surgery and Trauma) has been set up to allow to all the EGS (Emergency General Surgery) and Trauma surgeons to register their activity and to obtain a worldwide register of traumatic and non traumatic surgical emergencies. This will give the opportunity to evaluate results on a macro-data basis and to give index allowing stratifying, evaluating and improving the outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients affected by an acute surgical disease and/or who may require to be undergone to the emergency surgeon attention to be managed either with an operative or a non-operative approach.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients affected by an acute surgical disease\n* Patients with indication to be referred to the emergency surgeon attention\n* Patients to be operated or to be treated with non-operative approach without surgical intervention\n\nExclusion Criteria:\n\n* Patients not affected by an acute surgical disease\n* Patients without indication to be referred to the emergency surgeon attention'}, 'identificationModule': {'nctId': 'NCT03643718', 'acronym': 'WIRES-T', 'briefTitle': 'Web-based International Register of Emergency Surgery and Trauma', 'organization': {'class': 'OTHER', 'fullName': 'A.O. Ospedale Papa Giovanni XXIII'}, 'officialTitle': 'Web-based International Register of Emergency Surgery and Trauma', 'orgStudyIdInfo': {'id': 'FC-001-2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Emergency General Surgery', 'type': 'PROCEDURE', 'otherNames': ['Trauma'], 'description': 'Emergency General Surgery and Trauma operative/non operative management'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federico Coccolini, MD', 'role': 'CONTACT', 'email': 'federico.coccolini@gmail.com', 'phone': '050-996123'}], 'facility': 'General, Emergency and Trauma surgery, University Hospital of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'centralContacts': [{'name': 'Federico Coccolini, MD', 'role': 'CONTACT', 'email': 'federico.coccolini@gmail.com', 'phone': '0039-050996123'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O. Ospedale Papa Giovanni XXIII', 'class': 'OTHER'}, 'collaborators': [{'name': 'World Society of Emergency Surgery', 'class': 'OTHER'}, {'name': 'University of Pisa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Surgeon', 'investigatorFullName': 'Federico Coccolini, MD', 'investigatorAffiliation': 'University of Pisa'}}}}