Methods of Colonic Transendoscopic Enteral Tubing: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- The second cecal intubation time
研究概览
简要总结
Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.
详细描述
Our previous article has reported the method of colon TET. However, the investigators found that it was difficult to find the cavity because of the concentration of intestinal folds caused by the tube pulling after insertion of TET. It is well known that transparent cap-assisted colonoscopy is easier to flatten the semilunar folds and improve mucosal exposure. Here the investigators test the hypothesis that using transparent cap-assisted colonoscopy significantly decreases the second cecal intubation time which not only improve work efficiency, but also saves patients' anesthesia time and cost. Thus, the investigators design a prospective multicenter, randomized controlled trial. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diseases requiring total colonic administration and fecal microbiota transplantation.
- •Patients and healthy Volunteers with the need to sample in deep colon .
- •Age > 7 years.
- •Must be able to Colonic Transendoscopic Enteral Tubing and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.
排除标准
- •Data was not recorded as required; Before and after implantation is not the same physician operation.
结局指标
主要结局
The second cecal intubation time
时间窗: one day
Record the time of colonoscopy from the anus to the ileal flap in the second insertion.
次要结局
- Adverse events rate(All patients were followed up from date of intubation to one mouth after discharge)
- Maximum insertion pain score(one day)
- TET success rate(one day)
- Retention time of tube(three month)
- Tubing time(one day)
- Titanium clip fixation time(one day)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University