The Diagnostic Methods of Crohn's Disease Flare-up Within One Month After Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- flare-up confirmed by coloscopy
研究概览
简要总结
Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high rate of postoperative anastomotic complications and recurrences. Surgery itself can influence immunologic function and trigger inflammatory response, which may result in the flare of Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to the the complexity of perioperative period and dangerous of invasive examine, it is difficult to distinguish disease flare from postoperative complications.
In this study, the investigators aim to development a diagnostic method of flare-up within one month after surgery, which can help us to detect and then treat disease flare in time.
详细描述
HBI score, serum CRP, ESR, WBC, Hb, PLT, IL-6，PCT and fecal Calprotectin will be monitored within one month after resection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis,
排除标准
- •patients have an anastomosis which is endoscopically inaccessible by standard colonoscopy;
- •patients withs persisting macroscopic abnormality after surgical resection;
- •patients with an end stoma (ileostomy or colostomy);
- •patients are not suitable to undergo endoscopy because of co-morbidities or an unwell clinical state;
- •patients who are unable to give informed consent;
- •patients who are pregnant
结局指标
主要结局
flare-up confirmed by coloscopy
时间窗: one month after surgery
次要结局
未报告次要终点
研究者
Zhu Weiming
Professor
Jinling Hospital, China