Multicenter Prospective Non-randomized Study: Predictors of Colectomy in Patients With Extremely Severe Ulcerative Colitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Inpatient colectomy rate
研究概览
简要总结
The purpose of this study is prove the need to selection of a extremely severe ulcerative colitis, to identify predictors of colectomy, which will reduce the optimal time for surgery.
详细描述
Acute severe ulcerative colitis is a life threatening disease,total mortality rate can reach 17%, and the frequency of surgical treatment approximately 40%. Standard conservative therapy in these patients is often ineffective and the optimal timing of the surgical treatment has not yet been established.
In the Russian clinical guidelines for the treatment of ulcerative colitis, the extremely severe ulcerative colitis is added to the classification of the severity.
The extremely severe ulcerative colitis is a severe, according to the criteria of Truelove, Witts and the endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction.
Conservative treatment of patients with extremely severe ulcerative colitis worsens treatment outcomes only. The authors of the study want to prove that patients with a extremely severe ulcerative colitis need a colectomy in a short time.
Is there a need for long-term follow-up, conservative treatment of high-risk patients? Is it safe to perform early surgical treatment without long-term conservative treatment? This study will allow to answer these questions and help doctors in the treatment of such patients anywhere in Russia and not only.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Acute Severe Colitis according to the Truelove and Witt's Criteria;
- •Extremely severe activity according endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction (lower 31 g/l).
排除标准
- •Pregnancy;
- •Infectious, ischemic colitis;
- •Transformation of diagnosis into Crohn's disease;
- •Medical treatment failure before the admission.
结局指标
主要结局
Inpatient colectomy rate
时间窗: 30 days
Operation performed due to the treatment failure and complications during hospitalization.
次要结局
- Long-term colectomy rate(12 months)
- Postoperative complications(12 months)
- Total mortality(12 months)
研究者
Achkasov Sergey
Achkasov Sergey, Professor of State Scientific Centre of Coloproctology, Head of sugery and oncology of colon department, Moscow
State Scientific Centre of Coloproctology, Russian Federation