Argentine Registry of Crohn's Disease and Ulcerative Colitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGrupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Suspected IBD diagnosis without confirmation

IBD patients with incomplete information about therapy and follow-up

Trial 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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • observational study

    Other intervention

    Observational registry without clinical interventions

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Demography

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

Time frame
Observational from July-2023

Secondary outcomes

1

Safety aspects of IBD patients

Safety aspects, including infections, and access to healthcare

Time frame
Observational from July-2023

Other outcomes

1

Therapy efectiveness

For the treatment effectiveness outcome, information about IBD complications as flares, need of hospitalization and surgery will be included

Time frame
Observational from July-2023

Sponsors and contacts

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