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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02758860




Registration number
NCT02758860
Ethics application status
Date submitted
23/04/2016
Date registered
3/05/2016
Date last updated
18/05/2022

Titles & IDs
Public title
Predictive Value of DICA in the Diverticular Disease of the Colon
Scientific 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.
Secondary ID [1] 0 0
DICA Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Diverticula 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Colonoscopy

Treatment: Surgery: Colonoscopy
Patients will be submitted to diagnostic colonoscopy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DICA score and diverticulitis
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
DICA score and surgery
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
DICA score and therapy
Timepoint [2] 0 0
3 years

Eligibility
Key inclusion criteria
- Endoscopic diagnosis of diverticula in the colon
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2020
Sample size
Target
Accrual to date
Final
2215
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Goiás
Country [2] 0 0
Italy
State/province [2] 0 0
Chieti
Country [3] 0 0
Italy
State/province [3] 0 0
Latina
Country [4] 0 0
Italy
State/province [4] 0 0
Lecce
Country [5] 0 0
Italy
State/province [5] 0 0
Macerata
Country [6] 0 0
Italy
State/province [6] 0 0
Milan
Country [7] 0 0
Italy
State/province [7] 0 0
Modena
Country [8] 0 0
Italy
State/province [8] 0 0
Napoli
Country [9] 0 0
Italy
State/province [9] 0 0
Perugia
Country [10] 0 0
Italy
State/province [10] 0 0
Rieti
Country [11] 0 0
Italy
State/province [11] 0 0
Roma
Country [12] 0 0
Italy
State/province [12] 0 0
Rome
Country [13] 0 0
Italy
State/province [13] 0 0
Taranto
Country [14] 0 0
Italy
State/province [14] 0 0
Vicenza
Country [15] 0 0
Italy
State/province [15] 0 0
Viterbo
Country [16] 0 0
Italy
State/province [16] 0 0
Andria
Country [17] 0 0
Italy
State/province [17] 0 0
Bari
Country [18] 0 0
Italy
State/province [18] 0 0
Cagliari
Country [19] 0 0
Italy
State/province [19] 0 0
Catanzaro
Country [20] 0 0
Italy
State/province [20] 0 0
L'Aquila
Country [21] 0 0
Italy
State/province [21] 0 0
Palermo
Country [22] 0 0
Italy
State/province [22] 0 0
Parma
Country [23] 0 0
Italy
State/province [23] 0 0
Reggio Emilia
Country [24] 0 0
Italy
State/province [24] 0 0
Turin
Country [25] 0 0
Italy
State/province [25] 0 0
Udine
Country [26] 0 0
Lithuania
State/province [26] 0 0
Vilnius
Country [27] 0 0
Poland
State/province [27] 0 0
Warsaw
Country [28] 0 0
Romania
State/province [28] 0 0
Cluj
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London
Country [30] 0 0
Venezuela
State/province [30] 0 0
Caracas

Funding & Sponsors
Primary sponsor type
Other
Name
University of Roma La Sapienza
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02758860
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Antonio Tursi, MD
Address 0 0
Gastroenterology Service , ASL BAT, Andria (BT) - Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02758860