Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT02758860
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2016-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of DICA in the Diverticular Disease of the Colon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Germany', 'Hungary', 'Mexico', 'Norway', 'Slovenia', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004241', 'term': 'Diverticulum, Colon'}], 'ancestors': [{'id': 'D004240', 'term': 'Diverticulum'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2215}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2016-04-23', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DICA score and diverticulitis', 'timeFrame': '3 years', 'description': 'Correlation between appearance of diverticulitis and DICA score.'}], 'secondaryOutcomes': [{'measure': 'DICA score and surgery', 'timeFrame': '3 years', 'description': 'Correlation between need to colonic surgery for complicated diverticular disease and DICA score.'}, {'measure': 'DICA score and therapy', 'timeFrame': '3 years', 'description': 'Correlation between response to treatment and DICA score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Diverticular disease of the colon', 'Classification'], 'conditions': ['Colonic Diverticula']}, 'referencesModule': {'references': [{'pmid': '25531499', 'type': 'RESULT', 'citation': 'Tursi A, Brandimarte G, Di Mario F, Andreoli A, Annunziata ML, Astegiano M, Bianco MA, Buri L, Cammarota G, Capezzuto E, Chilovi F, Cianci M, Conigliaro R, Del Favero G, Di Cesare L, Di Fonzo M, Elisei W, Faggiani R, Farroni F, Forti G, Germana B, Giorgetti GM, Giovannone M, Lecca PG, Loperfido S, Marmo R, Morucci P, Occhigrossi G, Penna A, Rossi AF, Spadaccini A, Zampaletta C, Zilli M, Zullo A, Scarpignato C, Picchio M. Development and validation of an endoscopic classification of diverticular disease of the colon: the DICA classification. Dig Dis. 2015;33(1):68-76. doi: 10.1159/000366039. Epub 2014 Dec 17.'}, {'pmid': '34702716', 'type': 'DERIVED', 'citation': "Tursi A, Brandimarte G, Di Mario F, Elisei W, Picchio M, Allegretta L, Annunziata ML, Bafutto M, Bassotti G, Bianco MA, Colucci R, Conigliaro R, Dumitrascu D, Escalante R, Ferrini L, Forti G, Franceschi M, Graziani MG, Lammert F, Latella G, Maconi G, Nardone G, Camara de Castro Oliveira L, Chaves Oliveira E, Papa A, Papagrigoriadis S, Pietrzak A, Pontone S, Poskus T, Pranzo G, Reichert MC, Rodino S, Regula J, Scaccianoce G, Scaldaferri F, Vassallo R, Zampaletta C, Zullo A, Piovani D, Bonovas S, Danese S; DICA International Group. Prognostic performance of the 'DICA' endoscopic classification and the 'CODA' score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study. Gut. 2022 Jul;71(7):1350-1358. doi: 10.1136/gutjnl-2021-325574. Epub 2021 Oct 26."}]}, 'descriptionModule': {'briefSummary': 'The Diverticular Inflammation and Complication Assessment (DICA) is an endoscopic classification for diverticulosis and diverticular disease of the colon.\n\nThe aim of the study is to show that DICA classification is a valid parameter to predict the risk of acute diverticulitis occurrence/recurrence and the need of surgery in patients suffering from diverticulosis/diverticular disease of the colon.', 'detailedDescription': 'The Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification has been recently developed for patients suffering from diverticulosis and diverticular disease.\n\nA recent multicentre, international, retrospective study found that DICA classification has a significant predictive value on the outcome of the disease in terms of acute diverticulitis occurrence/recurrence and surgery occurrence.\n\nThe aim of the present study is to confirm the above mentioned results propectively Several centers, worldwide distributed, will be involved. A minimum of 281 patients will be required for the study. This calculation will be based on the assumption that a continuity-corrected chi-square test with a type I error of 0.05 and a type II error of 0.20 will be expected to detect a difference between a 4.3% prevalence of diverticulitis in patients with diverticulosis and 8.6% in DICA I patients.\n\nOnly patients at the first endoscopic diagnosis of diverticulosis/diverticular disease will be enrolled. For each patient, we recorded: age; severity of DICA score; severity of symptoms at entry and during the follow-up; C-reactive protein (CRP) and fecal calprotectin test at the time of diagnosis and during the follow-up (CRP only for DICA 2 and 3 patients); comorbidities (if any); concomitant therapies (if any); therapy taken during the follow-up to maintain remission (if any); months of follow-up; occurrence/recurrence of acute diverticulitis; need of surgery.\n\nThe study will take three year. The investigators aim at confirming that DICA classification is a valid parameter to predict the risk of acute diverticulitis occurrence/recurrence and the need of surgery in patients suffering from diverticulosis/diverticular disease of the colon. This could permit to select populations at higher or lower risk, having or not benefit from scheduled (and type) treatment able to reduce those risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients accessing the endoscopic service', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endoscopic diagnosis of diverticula in the colon\n\nExclusion Criteria:\n\n* • Radiological signs (by abdominal CT or by ultrasounds) of acute diverticulitis (complicated or uncomplicated)\n\n * Inflammatory bowel diseases;\n * Ischemic colitis;\n * Prior colonic resection\n * Patients with severe liver failure (Child-Pugh C);\n * Patients with severe kidney failure;\n * Pregnant women;\n * Women of childbearing potential not using a highly effective method of contraception;\n * Patients who are currently using or who have received any laxative agents \\< 2 weeks prior to the enrollment;\n * Patients who are currently using or who have received mesalamine compounds \\< 2 weeks prior to the enrollment;\n * Patients who are currently using or who have received any probiotic agents \\< 2 weeks prior to the enrollment;\n * Nonsteroidal anti-inflammatory drug (NSAID) use \\< 1 week prior to the enrollment;\n * Patients who have received treatment with antibiotics (even those not absorbed) \\< 2 weeks prior to the enrollment;\n * Inability to comply with study protocol and to give informed consensus to the procedure;\n * Patients with or history of cancer, of any origin, within 5 years before enrollment\n * History of alcohol, drug, or chemical abuse\n * Any severe pathological condition that may interfere with the proper study execution.'}, 'identificationModule': {'nctId': 'NCT02758860', 'briefTitle': 'Predictive Value of DICA in the Diverticular Disease of the Colon', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Predictive Value of the Diverticular Inflammation and Complication Assessment (DICA) Endoscopic Classification on the Outcome of the Diverticular Disease of the Colon: a Prospective, Multicenter, International Study.', 'orgStudyIdInfo': {'id': 'DICA Trial'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colonoscopy', 'type': 'PROCEDURE', 'description': 'Patients will be submitted to diagnostic colonoscopy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Av, 470 - Hosp Ort de Goiania (St Aeroporto)', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Consultório R, 46 - 25 Clin de Gastroentero', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '66054', 'city': 'Vasto', 'state': 'Chieti', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"', 'geoPoint': {'lat': 42.1115, 'lon': 14.70649}}, {'zip': '04019', 'city': 'Terracina', 'state': 'Latina', 'country': 'Italy', 'facility': 'Sapienza University of Rome- Polo Pontino', 'geoPoint': {'lat': 41.29174, 'lon': 13.24359}}, {'zip': '73013', 'city': 'Galatina', 'state': 'Lecce', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "Santa Caterina Novella"', 'geoPoint': {'lat': 40.17416, 'lon': 18.17032}}, {'zip': '62012', 'city': 'Civitanova Marche', 'state': 'Macerata', 'country': 'Italy', 'facility': 'Servizio Gastroenterologia ed Endoscopia Digestiva, Casa di Cura "Villa dei Pini"', 'geoPoint': {'lat': 43.30491, 'lon': 13.72068}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'IBD Unit, Ospedale Universitario "Humanitas"', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Policlinico "San Donato"', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '41126', 'city': 'Baggiovara', 'state': 'Modena', 'country': 'Italy', 'facility': 'UO di Endoscopia Digestiva, Nuovo Ospedale Civile "Sant\'Agostino Estense"', 'geoPoint': {'lat': 44.60416, 'lon': 10.86256}}, {'zip': '80059', 'city': 'Torre del Greco', 'state': 'Napoli', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "T. Maresca"', 'geoPoint': {'lat': 40.78931, 'lon': 14.36806}}, {'zip': '06049', 'city': 'Spoleto', 'state': 'Perugia', 'country': 'Italy', 'facility': 'SS di Endoscopia Digestiva, Ospedale "San Matteo degli Infermi" Spoleto (PG)', 'geoPoint': {'lat': 42.74071, 'lon': 12.73899}}, {'zip': '02046', 'city': 'Magliano Sabina', 'state': 'Rieti', 'country': 'Italy', 'facility': 'Servizio di Gastroenterologia ed Endoscopia Digestiva, Casa della Salute Magliano Sabina', 'geoPoint': {'lat': 42.36568, 'lon': 12.4852}}, {'zip': '00041', 'city': 'Albano Laziale', 'state': 'Roma', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, ASL Roma 6', 'geoPoint': {'lat': 41.72748, 'lon': 12.659}}, {'zip': '00122', 'city': 'Ostia Antica', 'state': 'Rome', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"', 'geoPoint': {'lat': 41.75844, 'lon': 12.29971}}, {'zip': '00049', 'city': 'Velletri', 'state': 'Rome', 'country': 'Italy', 'facility': 'UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6', 'geoPoint': {'lat': 41.68573, 'lon': 12.77753}}, {'zip': '74015', 'city': 'Martina Franca', 'state': 'Taranto', 'country': 'Italy', 'facility': 'SSD di Endoscopia Digestiva, Ospedale "Valle d\'Itria', 'geoPoint': {'lat': 40.70355, 'lon': 17.33814}}, {'zip': '36014', 'city': 'Santorso', 'state': 'Vicenza', 'country': 'Italy', 'facility': 'UO Endoscopia Digestiva, ULSS4 Alto Vicentino,', 'geoPoint': {'lat': 45.73383, 'lon': 11.38785}}, {'zip': '01016', 'city': 'Tarquinia', 'state': 'Viterbo', 'country': 'Italy', 'facility': 'UOSD di Endoscopia Digestiva, Ospedale di Tarquinia', 'geoPoint': {'lat': 42.25419, 'lon': 11.75657}}, {'zip': '76123', 'city': 'Andria', 'country': 'Italy', 'facility': 'Gastroenterology Service , ASL BAT,', 'geoPoint': {'lat': 41.23117, 'lon': 16.29797}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Sezione di Medicina Interna, Clinica Medica "A. Murri", Policlinico Consorziale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '70132', 'city': 'Bari', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "San Paolo"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '09100', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'UO di Gastroenterologia - Policlinico del Monserrato, Università di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "Pugliese-Ciaccio"', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '04100', 'city': 'Latina', 'country': 'Italy', 'facility': 'U.O.D. di Endoscopia Digestiva, Ospedale "S. Maria Goretti"', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '0862', 'city': 'L’Aquila', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "San Salvatore", Università de L\'Aquila L\'Aquila', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, A.O. "L. Sacco" , Università di Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '90123', 'city': 'Palermo', 'country': 'Italy', 'facility': 'UOS di Gastroenterologia ed Endoscopia Digestiva- Ospedale "Bucchieri - La Ferla"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'UO di Gastroenterologia - Ospedale Maggiore, Università di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '06100', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Dipartimento di medicina Clinica e Sperimentale, Sezione di Gastroenterologia ed Epatologia Ospedale "Santa Maria della Misericordia" Hospital, Università di Perugia,', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '42100', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'SC di Gastroenterologia - Endoscopia Digestiva, IRCCS Arcispedale "Santa Maria Nuova"', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'UOD di Endoscopia Digestiva e Nutrizionale, Ospedale "S. Eugenio"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'UOC di Chirurgia Generale "I", Policlinico "Umberto I", Università "Sapienza"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00167', 'city': 'Rome', 'country': 'Italy', 'facility': 'UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'UOC di Medicina Interna e Gastroenterologia, C.I. "Columbus", Università Cattolica', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'UOC di Medicina Interna e Gastroenterologia, Policlinico "A. Gemelli"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00184', 'city': 'Rome', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia ed Endoscopia Digestiva, A.O. "S. Giovanni-Addolorata"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00198', 'city': 'Rome', 'country': 'Italy', 'facility': 'Servizio di Gastroenterologia ed Endoscopia Digestiva, PTP "Nuovo Regina Margherita"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '10121', 'city': 'Turin', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "Molinette"', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "Santa Maria della Misericordia"', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '01100', 'city': 'Viterbo', 'country': 'Italy', 'facility': 'UOC di Gastroenterologia, Ospedale "Belcolle"', 'geoPoint': {'lat': 42.41937, 'lon': 12.1056}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Postgraduate Education Centre; Department of Gastrointestinal Oncology, Maria Sklodowska-Curie Clinical Oncology Institute', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': '2nd Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Department of Colorectal Surgery, Kings College Hospital,', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Universidad Central de Venezuela, Loira Medical Center,', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'Antonio Tursi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastroenterology Service , ASL BAT, Andria (BT) - Italy'}, {'name': 'Giovanni Brandimarte, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Rome'}, {'name': 'Walter Elisei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOC di Gastroenterologia, ASL Roma 6 Albano Laziale (Rome)'}, {'name': 'Marcello Picchio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6 Velletri (Rome)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Erasmo Spaziani', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}