protocolSection identificationModule nctId: NCT06388538, orgStudyIdInfo id: Carlo Bergamini, briefTitle: The COLD2B Multicenter, Two-arm Prospective Cohort Study, acronym: COLD2B, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Azienda Sanitaria di Firenze, class: OTHER, descriptionModule briefSummary: Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, we launched the COLD2B study to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients.The primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study).Moreover, the two groups will be compared regarding mortality and morbidity (secondary end-point).The second arm of the study will consider the population undergoing surgery, develop a model able to predict the length of hospitalization, and compare the open vs laparoscopic approach (primary end-point), and mortality, morbidity, and surgical outcome indices (secondary end-point)., conditionsModule conditions: Acute Diverticulitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Conservative treatment (non-operative treatment), interventions name: Surgical treatment (operative treatment), outcomesModule primaryOutcomes measure: Length of hospital stay in the overall population, secondaryOutcomes measure: Morbidity rate for both arms, secondaryOutcomes measure: Mortality rate for both arms, secondaryOutcomes measure: Surgical complications rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari, city: Bari, country: Italy, contacts name: Francesco Paolo Prete, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy, city: Florence, zip: 50134, country: Italy, contacts name: Carlo Bergamini, MD, role: CONTACT, phone: +39(0)557949173, email: drcarlobergamini@gmail.com, contacts name: Carlo Bergamini, role: PRINCIPAL_INVESTIGATOR, contacts name: Alessio Giordano, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Department of Medicine, Surgery and Health Sciences, University of Trieste, city: Trieste, country: Italy, contacts name: Manuela Mastronardi, role: CONTACT, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana, city: Vittorio Veneto, country: Italy, contacts name: Giulia Montori, role: CONTACT, geoPoint lat: 45.98026, lon: 12.30065, hasResults: False