Predictive Value of DICA in the Diverticular Disease of the Colon
- Conditions
- Colonic Diverticula
- Registration Number
- NCT02758860
- Lead Sponsor
- University of Roma La Sapienza
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2215
- Endoscopic diagnosis of diverticula in the colon
-
• 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DICA score and diverticulitis 3 years Correlation between appearance of diverticulitis and DICA score.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (45)
Dipartimento di medicina Clinica e Sperimentale, Sezione di Gastroenterologia ed Epatologia Ospedale "Santa Maria della Misericordia" Hospital, Università di Perugia,
🇮🇹Perugia, Italy
UOC di Medicina Interna e Gastroenterologia, C.I. "Columbus", Università Cattolica
🇮🇹Rome, Italy
IBD Unit, Ospedale Universitario "Humanitas"
🇮🇹Rozzano, Milan, Italy
UOC di Gastroenterologia, Policlinico "San Donato"
🇮🇹San Donato Milanese, Milan, Italy
UOC di Gastroenterologia, Ospedale "T. Maresca"
🇮🇹Torre del Greco, Napoli, Italy
UOC di Gastroenterologia, ASL Roma 6
🇮🇹Albano Laziale, Roma, Italy
UOC di Gastroenterologia ed Endoscopia Chirurgica, Ospedale "Grassi"
🇮🇹Ostia, Rome, Italy
UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6
🇮🇹Velletri, Rome, 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
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
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
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, 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
SSD di Endoscopia Digestiva, Ospedale "Valle d'Itria
🇮🇹Martina Franca, Taranto, Italy
UO Endoscopia Digestiva, ULSS4 Alto Vicentino,
🇮🇹Santorso, Vicenza, Italy
UO di Endoscopia Digestiva, Nuovo Ospedale Civile "Sant'Agostino Estense"
🇮🇹Baggiovara, Modena, Italy
UOC di Gastroenterologia, Ospedale "San Pio da Pietrelcina"
🇮🇹Vasto, Chieti, Italy
Sapienza University of Rome- Polo Pontino
🇮🇹Terracina, Latina, Italy
Av, 470 - Hosp Ort de Goiania (St Aeroporto)
🇧🇷Goiânia, Goiás, Brazil
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
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
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
Consultório R, 46 - 25 Clin de Gastroentero
🇧🇷Goiânia, Goiás, Brazil
UOSD di Endoscopia Digestiva, Ospedale di Tarquinia
🇮🇹Tarquinia, Viterbo, Italy
Centre for abdominal surgery, Vilnius University Hospital Santariskiu Klinikos,
🇱🇹Vilnius, Lithuania
Universidad Central de Venezuela, Loira Medical Center,
🇻🇪Caracas, Venezuela
Department of Colorectal Surgery, Kings College Hospital,
🇬🇧London, United Kingdom