Predictive Value of DICA in the Diverticular Disease of the Colon

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT02758860

Collaborator

(none)

2,215

Enrollment

Locations

Actual Duration (Months)

49.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Diverticula	Procedure: Colonoscopy

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2215 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Sep 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Outcome Measures

Primary Outcome Measures

DICA score and diverticulitis [3 years]
Correlation between appearance of diverticulitis and DICA score.

Secondary Outcome Measures

DICA score and surgery [3 years]
Correlation between need to colonic surgery for complicated diverticular disease and DICA score.
DICA score and therapy [3 years]
Correlation between response to treatment and DICA score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Av, 470 - Hosp Ort de Goiania (St Aeroporto)	Goiânia	Goiás	Brazil
2	Consultório R, 46 - 25 Clin de Gastroentero	Goiânia	Goiás	Brazil
3	UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"	Vasto	Chieti	Italy	66054
4	Sapienza University of Rome- Polo Pontino	Terracina	Latina	Italy	04019
5	UOC di Gastroenterologia, Ospedale "Santa Caterina Novella"	Galatina	Lecce	Italy	73013
6	Servizio Gastroenterologia ed Endoscopia Digestiva, Casa di Cura "Villa dei Pini"	Civitanova Marche	Macerata	Italy	62012
7	IBD Unit, Ospedale Universitario "Humanitas"	Rozzano	Milan	Italy	20089
8	UOC di Gastroenterologia, Policlinico "San Donato"	San Donato Milanese	Milan	Italy	20097
9	UO di Endoscopia Digestiva, Nuovo Ospedale Civile "Sant'Agostino Estense"	Baggiovara	Modena	Italy	41126
10	UOC di Gastroenterologia, Ospedale "T. Maresca"	Torre del Greco	Napoli	Italy	80059
11	SS di Endoscopia Digestiva, Ospedale "San Matteo degli Infermi" Spoleto (PG)	Spoleto	Perugia	Italy	06049
12	Servizio di Gastroenterologia ed Endoscopia Digestiva, Casa della Salute Magliano Sabina	Magliano Sabina	Rieti	Italy	02046
13	UOC di Gastroenterologia, ASL Roma 6	Albano Laziale	Roma	Italy	00041
14	UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"	Ostia	Rome	Italy	00122
15	UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6	Velletri	Rome	Italy	00049
16	SSD di Endoscopia Digestiva, Ospedale "Valle d'Itria	Martina Franca	Taranto	Italy	74015
17	UO Endoscopia Digestiva, ULSS4 Alto Vicentino,	Santorso	Vicenza	Italy	36014
18	UOSD di Endoscopia Digestiva, Ospedale di Tarquinia	Tarquinia	Viterbo	Italy	01016
19	Gastroenterology Service , ASL BAT,	Andria		Italy	76123
20	Sezione di Medicina Interna, Clinica Medica "A. Murri", Policlinico Consorziale	Bari		Italy	70124
21	UOC di Gastroenterologia, Ospedale "San Paolo"	Bari		Italy	70132
22	UO di Gastroenterologia - Policlinico del Monserrato, Università di Cagliari	Cagliari		Italy	09100
23	UOC di Gastroenterologia, Ospedale "Pugliese-Ciaccio"	Catanzaro		Italy	88100
24	UOC di Gastroenterologia, Ospedale "San Salvatore", Università de L'Aquila L'Aquila	L'Aquila		Italy	0862
25	U.O.D. di Endoscopia Digestiva, Ospedale "S. Maria Goretti"	Latina		Italy	04100
26	UOC di Gastroenterologia, A.O. "L. Sacco" , Università di Milano	Milan		Italy	20133
27	UOS di Gastroenterologia ed Endoscopia Digestiva- Ospedale "Bucchieri - La Ferla"	Palermo		Italy	90123
28	UO di Gastroenterologia - Ospedale Maggiore, Università di Parma	Parma		Italy	43100
29	Dipartimento di medicina Clinica e Sperimentale, Sezione di Gastroenterologia ed Epatologia Ospedale "Santa Maria della Misericordia" Hospital, Università di Perugia,	Perugia		Italy	06100
30	SC di Gastroenterologia - Endoscopia Digestiva, IRCCS Arcispedale "Santa Maria Nuova"	Reggio Emilia		Italy	42100
31	UOD di Endoscopia Digestiva e Nutrizionale, Ospedale "S. Eugenio"	Rome		Italy	00144
32	UOC di Chirurgia Generale "I", Policlinico "Umberto I", Università "Sapienza"	Rome		Italy	00161
33	UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Roma	Rome		Italy	00167
34	UOC di Medicina Interna e Gastroenterologia, C.I. "Columbus", Università Cattolica	Rome		Italy	00168
35	UOC di Medicina Interna e Gastroenterologia, Policlinico "A. Gemelli"	Rome		Italy	00168
36	UOC di Gastroenterologia ed Endoscopia Digestiva, A.O. "S. Giovanni-Addolorata"	Rome		Italy	00184
37	Servizio di Gastroenterologia ed Endoscopia Digestiva, PTP "Nuovo Regina Margherita"	Rome		Italy	00198
38	UOC di Gastroenterologia, Ospedale "Molinette"	Turin		Italy	10121
39	UOC di Gastroenterologia, Ospedale "Santa Maria della Misericordia"	Udine		Italy	33100
40	UOC di Gastroenterologia, Ospedale "Belcolle"	Viterbo		Italy	01100
41	Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,	Vilnius		Lithuania
42	Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Postgraduate Education Centre; Department of Gastrointestinal Oncology, Maria Sklodowska-Curie Clinical Oncology Institute	Warsaw		Poland
43	2nd Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy	Cluj-Napoca	Cluj	Romania
44	Department of Colorectal Surgery, Kings College Hospital,	London		United Kingdom
45	Universidad Central de Venezuela, Loira Medical Center,	Caracas		Venezuela

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Principal Investigator: Antonio Tursi, MD, Gastroenterology Service , ASL BAT, Andria (BT) - Italy
Study Director: Giovanni Brandimarte, MD, UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Rome
Principal Investigator: 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)