跳至主要内容
临床试验/NCT04740957
NCT04740957招募中不适用

Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing

Imperial College London1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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