Evaluation of PUCAI Score at Assessment for Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mucusa healing according to the MAYO score
研究概览
简要总结
Establishing that mucosal healing (MH) has occurred after therapy is an important treatment goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has demonstrated good correlations for clinical remission and disease severity, but its role for establishing mucosal healing after therapy has not been validated . The ability to predict mucosal healing may be different for patients in long term remission compared to assessment after obtaining clinical remission. No previous study has prospectively validated the use of PUCAI as a proxy for MH specifically during clinical remission after therapy.
详细描述
All pediatric patients ≤ 19 years old and at the Wolfson Medical Center pediatric IBD center who enter clinical remission are routinely assessed by colposcopy or sigmoidoscopy assess. This is an analysis of prospectively collected data regarding PUCAI and endoscopic Mayo score at the time of assessment of mucosal healing by endoscopy. Patients could be included if they have establish ulcerative colitis, while they are on remission for at least 3 months after treatment of flare. For this study, complete clinical remission was absence of abdominal pain, and no diarrhea or bleeding (PUCAI<10). sigmoidoscopy will be performed between 12-24 weeks after remission was documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 4 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative Colitis patient
- •clinical remission (PUCAI<10) for at least 3 months.
- •Sigmoidoscopy for assessment mucusa healing after therapy performed between 12-24 weeks after remission was documented
排除标准
- 未提供
结局指标
主要结局
Mucusa healing according to the MAYO score
时间窗: cross sectional study, the data will be reported during 4 years
present of endoscopic disease defined by mayo score
次要结局
未报告次要终点
研究者
Prof. Arie Levine
Director, Pediatric Gastroenterology and Nutrition unit
Wolfson Medical Center