Predictive Value of DICA in the Diverticular Disease of the Colon

NCT ID: NCT02758860

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-09-30

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.

Conditions

Colonic Diverticula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Colonoscopy

Patients will be submitted to diagnostic colonoscopy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Erasmo Spaziani

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Tursi, MD

Role: PRINCIPAL_INVESTIGATOR

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

Giovanni Brandimarte, MD

Role: STUDY_DIRECTOR

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

Walter Elisei, MD

Role: PRINCIPAL_INVESTIGATOR

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

Marcello Picchio, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Goiânia, Goiás, Brazil

Consultório R, 46 - 25 Clin de Gastroentero

Goiânia, Goiás, Brazil

UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"

Vasto, Chieti, Italy

Sapienza University of Rome- Polo Pontino

Terracina, Latina, Italy

UOC di Gastroenterologia, Ospedale "Santa Caterina Novella"

Galatina, Lecce, Italy

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

Civitanova Marche, Macerata, Italy

IBD Unit, Ospedale Universitario "Humanitas"

Rozzano, Milan, Italy

UOC di Gastroenterologia, Policlinico "San Donato"

San Donato Milanese, Milan, Italy

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

Baggiovara, Modena, Italy

UOC di Gastroenterologia, Ospedale "T. Maresca"

Torre del Greco, Napoli, Italy

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

Spoleto, Perugia, Italy

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

Magliano Sabina, Rieti, Italy

UOC di Gastroenterologia, ASL Roma 6

Albano Laziale, Roma, Italy

UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"

Ostia Antica, Rome, Italy

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

Velletri, Rome, Italy

SSD di Endoscopia Digestiva, Ospedale "Valle d'Itria

Martina Franca, Taranto, Italy

UO Endoscopia Digestiva, ULSS4 Alto Vicentino,

Santorso, Vicenza, Italy

UOSD di Endoscopia Digestiva, Ospedale di Tarquinia

Tarquinia, Viterbo, Italy

Gastroenterology Service , ASL BAT,

Andria, , Italy

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

Bari, , Italy

UOC di Gastroenterologia, Ospedale "San Paolo"

Bari, , Italy

UO di Gastroenterologia - Policlinico del Monserrato, Università di Cagliari

Cagliari, , Italy

UOC di Gastroenterologia, Ospedale "Pugliese-Ciaccio"

Catanzaro, , Italy

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

Latina, , Italy

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

L’Aquila, , Italy

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

Milan, , Italy

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

Palermo, , Italy

UO di Gastroenterologia - Ospedale Maggiore, Università di Parma

Parma, , Italy

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

Perugia, , Italy

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

Reggio Emilia, , Italy

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

Rome, , Italy

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

Rome, , Italy

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

Rome, , Italy

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

Rome, , Italy

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

Rome, , Italy

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

Rome, , Italy

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

Rome, , Italy

UOC di Gastroenterologia, Ospedale "Molinette"

Turin, , Italy

UOC di Gastroenterologia, Ospedale "Santa Maria della Misericordia"

Udine, , Italy

UOC di Gastroenterologia, Ospedale "Belcolle"

Viterbo, , Italy

Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,

Vilnius, , Lithuania

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

Warsaw, , Poland

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

Cluj-Napoca, Cluj, Romania

Department of Colorectal Surgery, Kings College Hospital,

London, , United Kingdom

Universidad Central de Venezuela, Loira Medical Center,

Caracas, , Venezuela

Countries

Brazil; Italy; Lithuania; Poland; Romania; United Kingdom; Venezuela

References

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.

Reference Type: RESULT

PMID: 25531499 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34702716 (View on PubMed)

Other Identifiers

DICA Trial

Identifier Type: -

Identifier Source: org_study_id