Predictive Value of DICA in the Diverticular Disease of the Colon

NCT02758860 | Completed

• 1 other identifier: DICA Trial
• Study Type: observational
• Target: 2,215
• Locations: 7 countries
• Sites: 45

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.

Conditions

Colonic Diverticula

Keywords

Colonoscopy; Diverticular disease of the colon; Classification

Outcome Measures

Primary Outcomes (1)

• DICA score and diverticulitis

  Correlation between appearance of diverticulitis and DICA score.

  3 years

Secondary Outcomes (2)

• DICA score and surgery

  3 years

• DICA score and therapy

  3 years

Interventions

Colonoscopy PROCEDURE

Patients will be submitted to diagnostic colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients accessing the endoscopic service

You may qualify if:

• Endoscopic diagnosis of diverticula in the colon

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (45)

Av, 470 - Hosp Ort de Goiania (St Aeroporto)

Goiânia, Goiás, Brazil

Location

Consultório R, 46 - 25 Clin de Gastroentero

Goiânia, Goiás, Brazil

Location

UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"

Vasto, Chieti, 66054, Italy

Location

Sapienza University of Rome- Polo Pontino

Terracina, Latina, 04019, Italy

Location

UOC di Gastroenterologia, Ospedale "Santa Caterina Novella"

Galatina, Lecce, 73013, Italy

Location

Servizio Gastroenterologia ed Endoscopia Digestiva, Casa di Cura "Villa dei Pini"

Civitanova Marche, Macerata, 62012, Italy

Location

IBD Unit, Ospedale Universitario "Humanitas"

Rozzano, Milan, 20089, Italy

Location

UOC di Gastroenterologia, Policlinico "San Donato"

San Donato Milanese, Milan, 20097, Italy

Location

UO di Endoscopia Digestiva, Nuovo Ospedale Civile "Sant'Agostino Estense"

Baggiovara, Modena, 41126, Italy

Location

UOC di Gastroenterologia, Ospedale "T. Maresca"

Torre del Greco, Napoli, 80059, Italy

Location

SS di Endoscopia Digestiva, Ospedale "San Matteo degli Infermi" Spoleto (PG)

Spoleto, Perugia, 06049, Italy

Location

Servizio di Gastroenterologia ed Endoscopia Digestiva, Casa della Salute Magliano Sabina

Magliano Sabina, Rieti, 02046, Italy

Location

UOC di Gastroenterologia, ASL Roma 6

Albano Laziale, Roma, 00041, Italy

Location

UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"

Ostia Antica, Rome, 00122, Italy

Location

UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6

Velletri, Rome, 00049, Italy

Location

SSD di Endoscopia Digestiva, Ospedale "Valle d'Itria

Martina Franca, Taranto, 74015, Italy

Location

UO Endoscopia Digestiva, ULSS4 Alto Vicentino,

Santorso, Vicenza, 36014, Italy

Location

UOSD di Endoscopia Digestiva, Ospedale di Tarquinia

Tarquinia, Viterbo, 01016, Italy

Location

Gastroenterology Service , ASL BAT,

Andria, 76123, Italy

Location

Sezione di Medicina Interna, Clinica Medica "A. Murri", Policlinico Consorziale

Bari, 70124, Italy

Location

UOC di Gastroenterologia, Ospedale "San Paolo"

Bari, 70132, Italy

Location

UO di Gastroenterologia - Policlinico del Monserrato, Università di Cagliari

Cagliari, 09100, Italy

Location

UOC di Gastroenterologia, Ospedale "Pugliese-Ciaccio"

Catanzaro, 88100, Italy

Location

U.O.D. di Endoscopia Digestiva, Ospedale "S. Maria Goretti"

Latina, 04100, Italy

Location

UOC di Gastroenterologia, Ospedale "San Salvatore", Università de L'Aquila L'Aquila

L’Aquila, 0862, Italy

Location

UOC di Gastroenterologia, A.O. "L. Sacco" , Università di Milano

Milan, 20133, Italy

Location

UOS di Gastroenterologia ed Endoscopia Digestiva- Ospedale "Bucchieri - La Ferla"

Palermo, 90123, Italy

Location

UO di Gastroenterologia - Ospedale Maggiore, Università di Parma

Parma, 43100, Italy

Location

Dipartimento di medicina Clinica e Sperimentale, Sezione di Gastroenterologia ed Epatologia Ospedale "Santa Maria della Misericordia" Hospital, Università di Perugia,

Perugia, 06100, Italy

Location

SC di Gastroenterologia - Endoscopia Digestiva, IRCCS Arcispedale "Santa Maria Nuova"

Reggio Emilia, 42100, Italy

Location

UOD di Endoscopia Digestiva e Nutrizionale, Ospedale "S. Eugenio"

Rome, 00144, Italy

Location

UOC di Chirurgia Generale "I", Policlinico "Umberto I", Università "Sapienza"

Rome, 00161, Italy

Location

UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Roma

Rome, 00167, Italy

Location

UOC di Medicina Interna e Gastroenterologia, C.I. "Columbus", Università Cattolica

Rome, 00168, Italy

Location

UOC di Medicina Interna e Gastroenterologia, Policlinico "A. Gemelli"

Rome, 00168, Italy

Location

UOC di Gastroenterologia ed Endoscopia Digestiva, A.O. "S. Giovanni-Addolorata"

Rome, 00184, Italy

Location

Servizio di Gastroenterologia ed Endoscopia Digestiva, PTP "Nuovo Regina Margherita"

Rome, 00198, Italy

Location

UOC di Gastroenterologia, Ospedale "Molinette"

Turin, 10121, Italy

Location

UOC di Gastroenterologia, Ospedale "Santa Maria della Misericordia"

Udine, 33100, Italy

Location

UOC di Gastroenterologia, Ospedale "Belcolle"

Viterbo, 01100, Italy

Location

Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,

Vilnius, Lithuania

Location

Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Postgraduate Education Centre; Department of Gastrointestinal Oncology, Maria Sklodowska-Curie Clinical Oncology Institute

Warsaw, Poland

Location

2nd Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, Cluj, Romania

Location

Department of Colorectal Surgery, Kings College Hospital,

London, United Kingdom

Location

Universidad Central de Venezuela, Loira Medical Center,

Caracas, Venezuela

Location

Related Publications (2)

• 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: 25531499 RESULT

• 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.

  PMID: 34702716 DERIVED

MeSH Terms

Conditions

Diverticulum, Colon

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Antonio Tursi, MD

  Gastroenterology Service , ASL BAT, Andria (BT) - Italy

  PRINCIPAL INVESTIGATOR

• Giovanni Brandimarte, MD

  UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Rome

  STUDY DIRECTOR

• Walter Elisei, MD

  UOC di Gastroenterologia, ASL Roma 6 Albano Laziale (Rome)

  PRINCIPAL INVESTIGATOR

• Marcello Picchio, MD

  UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6 Velletri (Rome)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: May 3, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); LI (1); IT (38); VE (1); GB (1); BR (2); PL (1)