Argentine Registry of Crohn's Disease and Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,250
- 试验地点
- 1
- 主要终点
- Demography
研究概览
简要总结
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.
详细描述
Aims:
The primary objective of the registry is to create an IBD physicians' network in Argentina that captures pragmatic and relevant information from IBD patients in terms of demographic, clinical and diagnostic aspects. The secondary objective includes safety aspects, including infections, and access to healthcare. The tertiary objective is related to treatment effectiveness. For the treatment effectiveness outcome, information about IBD complications as flares, need of hospitalization and surgery will be included.
Structure of the registry:
The administrative structure of the registry includes an executive committee with an administrative and organizational role which is coordinating with the GADECCU steering committee; a scientific committee that evaluates and coordinates scientific initiatives and promotes specific new strategic projects of interest and approves requests for access to centralized data for research projects. Also, a methodological and regulatory team that provides methodological support to the registry and ensures the regulatory aspects in each institution or region. RADECCU includes a group of technical programmers who develop and provide support to the web platform that allows researchers to register and follow their patients.
Ethical aspects:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Suspected IBD diagnosis without confirmation
- •IBD patients with incomplete information about therapy and follow-up
结局指标
主要结局
Demography
时间窗: Observational from July-2023
Information from IBD patients in terms of demographic, clinical and diagnostic aspects
次要结局
- Safety aspects of IBD patients(Observational from July-2023)