Predictive Value of DICA in the Diverticular Disease of the Colon

Colonic Diverticula Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758860
• Other study ID #: DICA Trial
• Status: Completed
• Start date: June 2016
• Est. completion date: September 2020

Study information

• Verified date: May 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2215
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Diverticula
• Diverticulosis, Colonic
• Diverticulum
• Diverticulum, Colon

Intervention

Procedure:
• Colonoscopy
Patients will be submitted to diagnostic colonoscopy

Locations

Country	Name	City	State
Brazil	Av, 470 - Hosp Ort de Goiania (St Aeroporto)	Goiânia	Goiás
Brazil	Consultório R, 46 - 25 Clin de Gastroentero	Goiânia	Goiás
Italy	UOC di Gastroenterologia, ASL Roma 6	Albano Laziale	Roma
Italy	Gastroenterology Service , ASL BAT,	Andria
Italy	UO di Endoscopia Digestiva, Nuovo Ospedale Civile "Sant'Agostino Estense"	Baggiovara	Modena
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	Servizio Gastroenterologia ed Endoscopia Digestiva, Casa di Cura "Villa dei Pini"	Civitanova Marche	Macerata
Italy	UOC di Gastroenterologia, Ospedale "Santa Caterina Novella"	Galatina	Lecce
Italy	UOC di Gastroenterologia, Ospedale "San Salvatore", Università de L'Aquila L'Aquila	L'Aquila
Italy	U.O.D. di Endoscopia Digestiva, Ospedale "S. Maria Goretti"	Latina
Italy	Servizio di Gastroenterologia ed Endoscopia Digestiva, Casa della Salute Magliano Sabina	Magliano Sabina	Rieti
Italy	SSD di Endoscopia Digestiva, Ospedale "Valle d'Itria	Martina Franca	Taranto
Italy	UOC di Gastroenterologia, A.O. "L. Sacco" , Università di Milano	Milan
Italy	UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"	Ostia	Rome
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	Servizio di Gastroenterologia ed Endoscopia Digestiva, PTP "Nuovo Regina Margherita"	Rome
Italy	UOC di Chirurgia Generale "I", Policlinico "Umberto I", Università "Sapienza"	Rome
Italy	UOC di Gastroenterologia ed Endoscopia Digestiva, A.O. "S. Giovanni-Addolorata"	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 Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Roma	Rome
Italy	UOD di Endoscopia Digestiva e Nutrizionale, Ospedale "S. Eugenio"	Rome
Italy	IBD Unit, Ospedale Universitario "Humanitas"	Rozzano	Milan
Italy	UOC di Gastroenterologia, Policlinico "San Donato"	San Donato Milanese	Milan
Italy	UO Endoscopia Digestiva, ULSS4 Alto Vicentino,	Santorso	Vicenza
Italy	SS di Endoscopia Digestiva, Ospedale "San Matteo degli Infermi" Spoleto (PG)	Spoleto	Perugia
Italy	UOSD di Endoscopia Digestiva, Ospedale di Tarquinia	Tarquinia	Viterbo
Italy	Sapienza University of Rome- Polo Pontino	Terracina	Latina
Italy	UOC di Gastroenterologia, Ospedale "T. Maresca"	Torre del Greco	Napoli
Italy	UOC di Gastroenterologia, Ospedale "Molinette"	Turin
Italy	UOC di Gastroenterologia, Ospedale "Santa Maria della Misericordia"	Udine
Italy	UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"	Vasto	Chieti
Italy	UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6	Velletri	Rome
Italy	UOC di Gastroenterologia, Ospedale "Belcolle"	Viterbo
Lithuania	Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,	Vilnius
Poland	Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Postgraduate Education Centre; Department of Gastrointestinal Oncology, Maria Sklodowska-Curie Clinical Oncology Institute	Warsaw
Romania	2nd Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy	Cluj-Napoca	Cluj
United Kingdom	Department of Colorectal Surgery, Kings College Hospital,	London
Venezuela	Universidad Central de Venezuela, Loira Medical Center,	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Countries where clinical trial is conducted

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

References & Publications (1)

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, Germanà B, Giorget — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DICA score and diverticulitis	Correlation between appearance of diverticulitis and DICA score.	3 years
Secondary	DICA score and surgery	Correlation between need to colonic surgery for complicated diverticular disease and DICA score.	3 years
Secondary	DICA score and therapy	Correlation between response to treatment and DICA score.	3 years