ISRCTN60945764已完成未知
An international multicentre randomised controlled trial to assess the effect of Appendectomy on the Clinical Course of ulcerative colitis; UK arm
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 29/03/2023:
- •1. Histologically confirmed Ulcerative Colitis
- •2. Disease relapse within 12 months prior to randomisation medically treated until remission
- •3. In clinical remission at time of randomisation with partial Mayo score less than 3 and presumptive endoscopic Mayo subscore of 0 or 1, identified by either:
- •3.1. Colonoscopy (within 3 months) examining the full length of the colon and rectum
- •3.2. Sigmoidoscopy (within 3 months) examining the last part of the colon (sigmoid and rectum) with faecal calprotectin less than 150 ug/g (within 3 months)
- •3.3 FCP less than 150 µg/g (within 3 months) with a personal history of raised FCP levels (>500 µg/g) during a previous disease flare-up at any stage
- •4. Aged 18 or over
- •5. Patient able and willing to give written informed consent
- •Previous participant inclusion criteria as of 27/10/2021:
- •1. Histologically confirmed Ulcerative Colitis
- •2. Disease relapse within 12 months of randomisation medically treated until remission
- •3. In clinical remission at time of randomisation with partial Mayo score less than 3 and presumptive endoscopic Mayo subscore of 0 or 1, identified by either:
- •3.1. Colonoscopy (within 3 months) examining the full length of the colon and rectum
- •3.2. Sigmoidoscopy (within 3 months) examining the last part of the colon (sigmoid and rectum) with faecal calprotectin less than 150 ug/g
- •3.3 FCP less than 150 µg/g (within 3 months) with a personal history of raised FCP levels (>500 µg/g) during a previous disease flare-up at any stage
- •4. Aged 18 or over
- •5. Patient able and willing to give written informed consent
- •Previous participant inclusion criteria:
- •1. Histologically confirmed Ulcerative Colitis
- •2. Disease relapse within 12 months of randomisation medically treated until remission
- •3. In clinical remission at time of randomisation with partial Mayo score less than 3 and presumptive endoscopic Mayo subscore of 0 or 1, identified by endoscopy (within 3 months). The endoscopy will be either:
- •3.1. Colonoscopy examining the full length of the colon and rectum
- •3.2. Sigmoidoscopy examining the last part of the colon (sigmoid and rectum) with faecal calprotectin less than 150 ug/g
- •4. Aged 18 or over
- •5. Patient able and willing to give written informed consent
排除标准
- •Current participant exclusion criteria as of 27/10/2021:
- •1. Previous appendicectomy or other major abdominal surgery precluding safe laparoscopic appendicectomy
- •2. Any suspicion of Crohn’s disease
- •3. Disease recently treated with biologicals (within 3 months of randomisation)
- •4. Patients with significant comorbidity (e.g. unstable heart failure, liver or kidney failure, major lung co-morbidity)
- •Previous participant exclusion criteria:
- •1. Previous appendicectomy or other major abdominal surgery precluding safe laparoscopic appendicectomy
- •2. Any suspicion of Crohn’s disease
- •3. Disease recently treated with biologicals (within 3 months of randomisation)
- •4. Severe disease ever treated with biologicals and stopped due to secondary non-response
- •5. Toxic megacolon or severe ongoing active colitis at time of randomisation
- •6. Patients with significant comorbidity (e.g. unstable heart failure, liver or kidney failure, major lung co-morbidity)
研究者
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