Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anastomotic healing
研究概览
简要总结
This pilot study aims to investigate anastomotic healing and its underlying mechanisms at a mucosal level. It is a first-in-human study which will demonstrate the safety of post-operative endoscopic assessment of a colorectal anastomosis and provide preliminary data in order to power future interventional studies.
100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants.
Patients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected.
A subgroup of 20 patients with a defunctioning ileostomy will be recruited to an interventional arm. This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patients undergoing elective left sided colonic or rectal resections with primary anastomosis with or without diverting ileostomy.
排除标准
- •Inability to communicate in English
- •People who lack capacity to consent
- •Emergency colorectal resection whilst awaiting elective surgery
- •Permanent stoma formation
- •People on long term immunosuppressive medication
- •People on long term renal replacement therapy.
结局指标
主要结局
Anastomotic healing
时间窗: 1 year
Healing of the colorectal anastomosis when assessed endoscopically - with no visible defects in the anastomosis.
次要结局
- Failure of anastomotic healing(1 year)
