Clinical trial NCT02758860: Predictive Value of DICA in the Diverticular Disease of the Colon
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Diverticula
Keywords: Colonoscopy
Diverticular disease of the colon
Classification
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 2215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients accessing the endoscopic service

Brief summary: The Diverticular Inflammation and Complication Assessment (DICA) is an endoscopic classification for diverticulosis and diverticular disease of the colon.

The 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.

Detailed description: The Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification has been recently developed for patients suffering from diverticulosis and diverticular disease.

A 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.

The 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.

Only 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.

The 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.

Eligibility criteria: Inclusion Criteria:

* Endoscopic diagnosis of diverticula in the colon

Exclusion Criteria:

* • Radiological signs (by abdominal CT or by ultrasounds) of acute diverticulitis (complicated or uncomplicated)

  * Inflammatory bowel diseases;
  * Ischemic colitis;
  * Prior colonic resection
  * Patients with severe liver failure (Child-Pugh C);
  * Patients with severe kidney failure;
  * Pregnant women;
  * Women of childbearing potential not using a highly effective method of contraception;
  * Patients who are currently using or who have received any laxative agents \< 2 weeks prior to the enrollment;
  * Patients who are currently using or who have received mesalamine compounds \< 2 weeks prior to the enrollment;
  * Patients who are currently using or who have received any probiotic agents \< 2 weeks prior to the enrollment;
  * Nonsteroidal anti-inflammatory drug (NSAID) use \< 1 week prior to the enrollment;
  * Patients who have received treatment with antibiotics (even those not absorbed) \< 2 weeks prior to the enrollment;
  * Inability to comply with study protocol and to give informed consensus to the procedure;
  * Patients with or history of cancer, of any origin, within 5 years before enrollment
  * History of alcohol, drug, or chemical abuse
  * Any severe pathological condition that may interfere with the proper study execution.

Primary outcomes:
measure: DICA score and diverticulitis
timeFrame: 3 years
Secondary outcomes:
measure: DICA score and surgery
timeFrame: 3 years
measure: DICA score and therapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Av, 470 - Hosp Ort de Goiania (St Aeroporto)
state: Goiás
city: Goiânia
country: Brazil
facility: Consultório R, 46 - 25 Clin de Gastroentero
state: Goiás
city: Vasto
country: Italy
facility: UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"
state: Chieti
city: Terracina
country: Italy
facility: Sapienza University of Rome- Polo Pontino
state: Latina
city: Galatina
country: Italy
facility: UOC di Gastroenterologia, Ospedale "Santa Caterina Novella"
state: Lecce
city: Civitanova Marche
country: Italy
facility: Servizio Gastroenterologia ed Endoscopia Digestiva, Casa di Cura "Villa dei Pini"
state: Macerata
city: Rozzano
country: Italy
facility: IBD Unit, Ospedale Universitario "Humanitas"
state: Milan
city: San Donato Milanese
country: Italy
facility: UOC di Gastroenterologia, Policlinico "San Donato"
state: Milan
city: Baggiovara
country: Italy
facility: UO di Endoscopia Digestiva, Nuovo Ospedale Civile "Sant'Agostino Estense"
state: Modena
city: Torre del Greco
country: Italy
facility: UOC di Gastroenterologia, Ospedale "T. Maresca"
state: Napoli
city: Spoleto
country: Italy
facility: SS di Endoscopia Digestiva, Ospedale "San Matteo degli Infermi" Spoleto (PG)
state: Perugia
city: Magliano Sabina
country: Italy
facility: Servizio di Gastroenterologia ed Endoscopia Digestiva, Casa della Salute Magliano Sabina
state: Rieti
city: Albano Laziale
country: Italy
facility: UOC di Gastroenterologia, ASL Roma 6
state: Roma
city: Ostia
country: Italy
facility: UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"
state: Rome
city: Velletri
country: Italy
facility: UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6
state: Rome
city: Martina Franca
country: Italy
facility: SSD di Endoscopia Digestiva, Ospedale "Valle d'Itria
state: Taranto
city: Santorso
country: Italy
facility: UO Endoscopia Digestiva, ULSS4 Alto Vicentino,
state: Vicenza
city: Tarquinia
country: Italy
facility: UOSD di Endoscopia Digestiva, Ospedale di Tarquinia
state: Viterbo
city: Andria
country: Italy
facility: Gastroenterology Service , ASL BAT,
city: Bari
country: Italy
facility: Sezione di Medicina Interna, Clinica Medica "A. Murri", Policlinico Consorziale
city: Bari
country: Italy
facility: UOC di Gastroenterologia, Ospedale "San Paolo"
city: Cagliari
country: Italy
facility: UO di Gastroenterologia - Policlinico del Monserrato, Università di Cagliari
city: Catanzaro
country: Italy
facility: UOC di Gastroenterologia, Ospedale "Pugliese-Ciaccio"
city: L'Aquila
country: Italy
facility: UOC di Gastroenterologia, Ospedale "San Salvatore", Università de L'Aquila L'Aquila
city: Latina
country: Italy
facility: U.O.D. di Endoscopia Digestiva, Ospedale "S. Maria Goretti"
city: Milan
country: Italy
facility: UOC di Gastroenterologia, A.O. "L. Sacco" , Università di Milano
city: Palermo
country: Italy
facility: UOS di Gastroenterologia ed Endoscopia Digestiva- Ospedale "Bucchieri - La Ferla"
city: Parma
country: Italy
facility: UO di Gastroenterologia - Ospedale Maggiore, Università di Parma
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,
city: Reggio Emilia
country: Italy
facility: SC di Gastroenterologia - Endoscopia Digestiva, IRCCS Arcispedale "Santa Maria Nuova"
city: Rome
country: Italy
facility: UOD di Endoscopia Digestiva e Nutrizionale, Ospedale "S. Eugenio"
city: Rome
country: Italy
facility: UOC di Chirurgia Generale "I", Policlinico "Umberto I", Università "Sapienza"
city: Rome
country: Italy
facility: UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Roma
city: Rome
country: Italy
facility: UOC di Medicina Interna e Gastroenterologia, C.I. "Columbus", Università Cattolica
city: Rome
country: Italy
facility: UOC di Medicina Interna e Gastroenterologia, Policlinico "A. Gemelli"
city: Rome
country: Italy
facility: UOC di Gastroenterologia ed Endoscopia Digestiva, A.O. "S. Giovanni-Addolorata"
city: Rome
country: Italy
facility: Servizio di Gastroenterologia ed Endoscopia Digestiva, PTP "Nuovo Regina Margherita"
city: Turin
country: Italy
facility: UOC di Gastroenterologia, Ospedale "Molinette"
city: Udine
country: Italy
facility: UOC di Gastroenterologia, Ospedale "Santa Maria della Misericordia"
city: Viterbo
country: Italy
facility: UOC di Gastroenterologia, Ospedale "Belcolle"
city: Vilnius
country: Lithuania
facility: Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,
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
city: Cluj-Napoca
country: Romania
facility: 2nd Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy
state: Cluj
city: London
country: United Kingdom
facility: Department of Colorectal Surgery, Kings College Hospital,
city: Caracas
country: Venezuela
facility: Universidad Central de Venezuela, Loira Medical Center,
Study officials:
affiliation: Gastroenterology Service , ASL BAT, Andria (BT) - Italy
name: Antonio Tursi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Rome
name: Giovanni Brandimarte, MD
role: STUDY_DIRECTOR
affiliation: UOC di Gastroenterologia, ASL Roma 6 Albano Laziale (Rome)
name: Walter Elisei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6 Velletri (Rome)
name: Marcello Picchio, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.