Argentine Registry of Crohn's Disease and Ulcerative Colitis

NCT07155148 | Recruiting

• 1 other identifier: RADECCU
• Study Type: observational
• Target: 4,250
• Locations: 1 country
• Sites: 1

Brief Summary

RADECCU is a strictly observational IBD registry in Argentina. The registry is open to all practicing gastroenterologist in the country grouped within the Argentinean Crohn's and Ulcerative Colitis Group (GADECCU). The registry will include outcomes of routine clinical practice of patients with IBD including the pediatric and adult population.

Conditions

Epidemiology; Inflammatory Bowel Disease (IBD); Therapy

Keywords

Crohn's Disease; Ulcerative Colitis; Argentina; Registry; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Demography

  Information from IBD patients in terms of demographic, clinical and diagnostic aspects

  Observational from July-2023

Secondary Outcomes (1)

• Safety aspects of IBD patients

  Observational from July-2023

Other Outcomes (1)

• Therapy efectiveness

  Observational from July-2023

Interventions

observational study OTHER

Observational registry without clinical interventions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Target population: Any patient diagnosed with IBD defined by validated diagnostic criteria. In order to ensure the inclusion of all IBD patients in Argentina, the executive committee invites all centers associated to GADECCU and involved in the management of IBD patients, regardless of the volume of patients they are in charge of, including both public and private centers. To reduce the possibility of selection bias, each participating physician from each center should aim to include all patients seen in their practice or clinic.

You may qualify if:

• Any patient diagnosed with IBD defined by validated diagnostic criteria can be included into the registry. The criteria for IBD diagnosis were based on previously published criteria for IBD diagnosis, including clinical, endoscopic, laboratory, and histopathological aspects, as well as small bowel imaging studies

You may not qualify if:

• Suspected IBD diagnosis without confirmation
• IBD patients with incomplete information about therapy and follow-up

Sponsors & Collaborators

• Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (1)

Hospital Privado Universitario de Cordoba

Córdoba, Córdoba Province, 5016, Argentina

RECRUITING

Related Publications (5)

• Hracs L, Windsor JW, Gorospe J, Cummings M, Coward S, Buie MJ, Quan J, Goddard Q, Caplan L, Markovinovic A, Williamson T, Abbey Y, Abdullah M, Abreu MT, Ahuja V, Raja Ali RA, Altuwaijri M, Balderramo D, Banerjee R, Benchimol EI, Bernstein CN, Brunet-Mas E, Burisch J, Chong VH, Dotan I, Dutta U, El Ouali S, Forbes A, Forss A, Gearry R, Dao VH, Hartono JL, Hilmi I, Hodges P, Jones GR, Juliao-Banos F, Kaibullayeva J, Kelly P, Kobayashi T, Kotze PG, Lakatos PL, Lees CW, Limsrivilai J, Lo B, Loftus EV Jr, Ludvigsson JF, Mak JWY, Miao Y, Ng KK, Okabayashi S, Olen O, Panaccione R, Paudel MS, Quaresma AB, Rubin DT, Simadibrata M, Sun Y, Suzuki H, Toro M, Turner D, Iade B, Wei SC, Yamamoto-Furusho JK, Yang SK, Ng SC, Kaplan GG; Global IBD Visualization of Epidemiology Studies in the 21st Century (GIVES-21) Research Group. Global evolution of inflammatory bowel disease across epidemiologic stages. Nature. 2025 Jun;642(8067):458-466. doi: 10.1038/s41586-025-08940-0. Epub 2025 Apr 30.

  PMID: 40307548 BACKGROUND

• Mak JWY, Sun Y, Limsrivilai J, Abdullah M, Kaibullayeva J, Balderramo D, Vergara BI, Paudel MS, Banerjee R, Hilmi I, Ali RAR, Wei SC, Ng KK, Altuwaijri M, Kelly P, Yamamoto-Furusho JK, Kotze PG, Ahuja V, Chong VH, Dao HV, Abbey Y, Ching JYL, Ho A, Chan AKW, Bernstein CN, Gearry RB, Abreu M, Rubin DT, Dotan I, Hracs L, Kaplan GG, Ng SC; GIVES-21 Consortium. Development of the global inflammatory bowel disease visualization of epidemiology studies in the 21st century (GIVES-21). BMC Med Res Methodol. 2023 May 25;23(1):129. doi: 10.1186/s12874-023-01944-2.

  PMID: 37231405 BACKGROUND

• Balderramo D, Quaresma AB, Olivera PA, Savio MC, Villamil MPG, Panaccione R, Ng SC, Kaplan GG, Kotze PG. Challenges in the diagnosis and treatment of inflammatory bowel disease in Latin America. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):263-272. doi: 10.1016/S2468-1253(23)00284-4.

  PMID: 38340754 BACKGROUND

• Olivera PA, Balderramo D, Lasa JS, Zubiaurre I, Correa G, Lubrano P, Ruffinengo O, Yantorno M, Rausch A, Pinero G, Bolomo A, Amigo C, El-Hakeh J, Leonardi DB, Brion L, Sambuelli A. Real-world clinical characteristics and therapeutic strategies in patients with moderate-to-severe inflammatory bowel disease in Argentina: Data from the RISE-AR study. Gastroenterol Hepatol. 2025 Oct;48(8):502287. doi: 10.1016/j.gastrohep.2024.502287. Epub 2024 Nov 15. English, Spanish.

  PMID: 39549817 BACKGROUND

• Balderramo D, Trakal J, Herrera Najum P, Vivas M, Gonzalez R, Benavidez A, Lopez Villa D, Daino D, Raiden K, German A, Corzo MA, Ponce de Leon J, Ferrer L, German C, Balzola S, Idoeta A, Zarate F, Defago MR; Grupo Cordoba de Cooperacion para el Manejo y Estudio de la Enfermedad Inflamatoria Intestinal (CEMEI Group). High ulcerative colitis and Crohn's disease ratio in a population-based registry from Cordoba, Argentina. Dig Liver Dis. 2021 Jul;53(7):852-857. doi: 10.1016/j.dld.2021.01.006. Epub 2021 Jan 30.

  PMID: 33531211 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Domingo C Balderramo, MD, PhD

  Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: July 14, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)