Refining Clinical Practice in Ulcerative Colitis: The Prognostic Value of Histologic Remission - A Monocentric Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Incidence of Composite Outcome
研究概览
简要总结
This retrospective study examines patients with ulcerative colitis who initiated advanced therapy for their disease. In clinical practice, patients with only mild inflammation on endoscopy (Mayo Endoscopic Subscore 1, or MES1) often do not undergo treatment optimization or therapy change. We stratified these patients based on histologic findings from biopsy samples and compared them with patients who had greater endoscopic activity (MES2). We evaluated long-term outcomes, including surgery and hospitalization, to determine whether current management strategies for patients with mild endoscopic disease should be reconsidered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of UC (by routine clinical, radiographic, endoscopic and pathologic criteria);
- •Patients starting a new advanced treatment for UC (either biologic agents or small molecules);
- •Patients with endoscopic MES of 1 or 2 at the endoscopic reassessment (conducted after 12 ± 3 months following the initiation of advanced therapy)
排除标准
- •Patients with unclassified colitis or Crohn's disease;
- •Previous colonic surgery (eg. Pouch);
- •Patients for whom biopsies were not obtained at the time of endoscopic reassessment (conducted after 12 months following the initiation of advanced therapy);
结局指标
主要结局
Incidence of Composite Outcome
时间窗: From enrollment to end of follow-up at 36 months
The composite outcome includes any of the following events: escalation of medical therapy, hospitalization related to ulcerative colitis, or surgery related to ulcerative colitis
次要结局
未报告次要终点
研究者
Ferdinando D'amico
MD, PhD
IRCCS San Raffaele