Colonic DiverticulaNCT02758860
Predictive Value of DICA in the Diverticular Disease of the Colon
An observational study of Colonic Diverticula, run by University of Roma La Sapienza at 45 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diverticula
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 2,215 participants
- Where
- 45 sitesin 7 countries
- Study dates
- Jun 2016to Sep 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients accessing the endoscopic service
Who may be able to join
- Endoscopic diagnosis of diverticula in the colon
Who cannot join
- • 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
Italy38 sites
UOC di Gastroenterologia, ASL Roma 6
Albano Laziale, Roma, 00041
Gastroenterology Service , ASL BAT,
Andria, 76123
UO di Endoscopia Digestiva, Nuovo Ospedale Civile "Sant'Agostino Estense"
Baggiovara, Modena, 41126
Sezione di Medicina Interna, Clinica Medica "A. Murri", Policlinico Consorziale
Bari, 70124
UOC di Gastroenterologia, Ospedale "San Paolo"
Bari, 70132
UO di Gastroenterologia - Policlinico del Monserrato, Università di Cagliari
Cagliari, 09100
UOC di Gastroenterologia, Ospedale "Pugliese-Ciaccio"
Catanzaro, 88100
Servizio Gastroenterologia ed Endoscopia Digestiva, Casa di Cura "Villa dei Pini"
Civitanova Marche, Macerata, 62012
UOC di Gastroenterologia, Ospedale "Santa Caterina Novella"
Galatina, Lecce, 73013
UOC di Gastroenterologia, Ospedale "San Salvatore", Università de L'Aquila L'Aquila
L’Aquila, 0862
U.O.D. di Endoscopia Digestiva, Ospedale "S. Maria Goretti"
Latina, 04100
Servizio di Gastroenterologia ed Endoscopia Digestiva, Casa della Salute Magliano Sabina
Magliano Sabina, Rieti, 02046
SSD di Endoscopia Digestiva, Ospedale "Valle d'Itria
Martina Franca, Taranto, 74015
UOC di Gastroenterologia, A.O. "L. Sacco" , Università di Milano
Milan, 20133
UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"
Ostia Antica, Rome, 00122
UOS di Gastroenterologia ed Endoscopia Digestiva- Ospedale "Bucchieri - La Ferla"
Palermo, 90123
UO di Gastroenterologia - Ospedale Maggiore, Università di Parma
Parma, 43100
Dipartimento di medicina Clinica e Sperimentale, Sezione di Gastroenterologia ed Epatologia Ospedale "Santa Maria della Misericordia" Hospital, Università di Perugia,
Perugia, 06100
SC di Gastroenterologia - Endoscopia Digestiva, IRCCS Arcispedale "Santa Maria Nuova"
Reggio Emilia, 42100
UOD di Endoscopia Digestiva e Nutrizionale, Ospedale "S. Eugenio"
Rome, 00144
UOC di Chirurgia Generale "I", Policlinico "Umberto I", Università "Sapienza"
Rome, 00161
UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Roma
Rome, 00167
UOC di Medicina Interna e Gastroenterologia, C.I. "Columbus", Università Cattolica
Rome, 00168
UOC di Medicina Interna e Gastroenterologia, Policlinico "A. Gemelli"
Rome, 00168
UOC di Gastroenterologia ed Endoscopia Digestiva, A.O. "S. Giovanni-Addolorata"
Rome, 00184
Servizio di Gastroenterologia ed Endoscopia Digestiva, PTP "Nuovo Regina Margherita"
Rome, 00198
IBD Unit, Ospedale Universitario "Humanitas"
Rozzano, Milan, 20089
UOC di Gastroenterologia, Policlinico "San Donato"
San Donato Milanese, Milan, 20097
UO Endoscopia Digestiva, ULSS4 Alto Vicentino,
Santorso, Vicenza, 36014
SS di Endoscopia Digestiva, Ospedale "San Matteo degli Infermi" Spoleto (PG)
Spoleto, Perugia, 06049
UOSD di Endoscopia Digestiva, Ospedale di Tarquinia
Tarquinia, Viterbo, 01016
Sapienza University of Rome- Polo Pontino
Terracina, Latina, 04019
UOC di Gastroenterologia, Ospedale "T. Maresca"
Torre del Greco, Napoli, 80059
UOC di Gastroenterologia, Ospedale "Molinette"
Turin, 10121
UOC di Gastroenterologia, Ospedale "Santa Maria della Misericordia"
Udine, 33100
UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"
Vasto, Chieti, 66054
UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6
Velletri, Rome, 00049
UOC di Gastroenterologia, Ospedale "Belcolle"
Viterbo, 01100
Brazil2 sites
Av, 470 - Hosp Ort de Goiania (St Aeroporto)
Goiânia, Goiás
Consultório R, 46 - 25 Clin de Gastroentero
Goiânia, Goiás
Lithuania1 site
Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,
Vilnius
Poland1 site
Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Postgraduate Education Centre; Department of Gastrointestinal Oncology, Maria Sklodowska-Curie Clinical Oncology Institute
Warsaw
Romania1 site
2nd Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy
Cluj-Napoca, Cluj
United Kingdom1 site
Department of Colorectal Surgery, Kings College Hospital,
London
Venezuela1 site
Universidad Central de Venezuela, Loira Medical Center,
Caracas
About this study
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.
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.
Read the 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
- Being tested
- Colonoscopy
- Keywords
- Colonoscopy, Diverticular disease of the colon, Classification
- Medical subject headings
- Diverticulum, Colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Patients will be submitted to diagnostic colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
DICA score and diverticulitis
Correlation between appearance of diverticulitis and DICA score.
Measured: 3 years
Secondary outcomes (2)
DICA score and surgery
Correlation between need to colonic surgery for complicated diverticular disease and DICA score.
Measured: 3 years
DICA score and therapy
Correlation between response to treatment and DICA score.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic DiverticulaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,215 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erasmo Spaziani, University of Roma La Sapienza
- Investigators
- Antonio Tursi, MD, Principal investigator, Gastroenterology Service , ASL BAT, Andria (BT) - ItalyGiovanni Brandimarte, MD, Study director, UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" RomeWalter Elisei, MD, Principal investigator, UOC di Gastroenterologia, ASL Roma 6 Albano Laziale (Rome)Marcello Picchio, MD, Principal investigator, UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6 Velletri (Rome)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758860
- Sponsor's protocol ID
- DICA Trial
- Status last verified
- May 2022
- First submitted
- 23 Apr 2016
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25531499Tursi 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.
PubMed 34702716
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02758860
- Acronym / sponsor ID
- DICA Trial
- Conditions
- Colonic Diverticula
- Keywords
- Colonoscopy, Diverticular disease of the colon, Classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,215 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients accessing the endoscopic service
Key inclusion criteria (1 listed)
- Endoscopic diagnosis of diverticula in the colon
Key exclusion criteria (17 listed)
- • Radiological signs (by abdominal CT or by ultrasounds) of acute diverticulitis (complicated or uncomplicated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyPatients will be submitted to diagnostic colonoscopy | Procedure or surgery | – |
Primary outcome
DICA score and diverticulitis
Time frame: 3 years
Correlation between appearance of diverticulitis and DICA score.
2 secondary outcomes
DICA score and surgery
Time frame: 3 years
DICA score and therapy
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Results publication: PubMed 25531499Tursi 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.
- Derived from this study: PubMed 34702716Tursi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Tursi, MD principal investigator
Gastroenterology Service , ASL BAT, Andria (BT) - Italy
Giovanni Brandimarte, MD study director
UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Rome
Walter Elisei, MD principal investigator
UOC di Gastroenterologia, ASL Roma 6 Albano Laziale (Rome)
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Diverticula, run by University of Roma La Sapienza at 45 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Italy, Brazil, Lithuania, Poland, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DICA score and diverticulitis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.