Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique (WAVE): a Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Insertion time
研究概览
简要总结
The colonoscopy procedure involves insertion of a thin, flexible tube with a tiny camera inside (colonoscope) passed inside the bowel. To allow passage of the colonoscope and adequate visualisation of the lining of the bowel wall a range of techniques can be used. During colonoscopy, you can distend the colon with water, CO2 and air.
Air is no longer recommended for gas insufflation during colonoscopy as it causes pain and excess bowel distention. So the options are water and/or CO2 but it is not entirely clear which combination is the best and at what point during the colonoscopy.
In practice, a hybrid technique where both CO2 and water are used during the colonoscopy in used. Here, water is exclusively used to help navigate the sigmoid colon with air pockets suctioned and turbid water exchanged with clean water. From splenic flexure to caecum a mixture of water and CO2 is used.
The aim of this study is to assess procedure comfort and efficiency of two different colonoscopy insertion techniques: water-alone insertion of the colonoscope (gas insufflation not allowed on insertion; water exchange technique) versus water-CO2 hybrid insertion (water used predominately to splenic flexure with water/CO2 used to caecum; modified water immersion technique).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •Capacity to consent
排除标准
- •Pregnancy
- •Previous bowel surgery
- •Unable to consent
研究组 & 干预措施
Water-alone colonoscopy (water exchange technique)
During water-alone colonoscopy, gas insufflation (air or CO2) is not allowed during the insertion of the colonoscope to the caecum. Instead, water is used to facilitate the passage of the scope to the caecum. On withdrawal, CO2 is permitted.
干预措施: Colonoscopy insertion technique used during procedure (Other)
Water-CO2 hybrid colonoscopy (modified water immersion technique)
During water-CO2 hybrid colonoscopy, the operator has access to both water and CO2. In the left colon, predominately water is used to navigate the sigmoid. Once the splenic flexure is reached, a combination of water and CO2 is used to reach the caecum. On withdrawal, CO2 is permitted.
干预措施: Colonoscopy insertion technique used during procedure (Other)
结局指标
主要结局
Insertion time
时间窗: During procedure
Time taken to insert the colonoscope
Total procedure time
时间窗: During procedure
Time taken to insert and withdraw the colonoscope
次要结局
- Loop formation(During procedure)
- Adenoma detection rate(1 week after procedure with results of histology)
- Serrated polyp detection rate(1 week after procedure with results of histology)
- Caecal intubation rate(During procedure)
- Patient discomfort scores(Immediately after procedure)
- Number of ancilliary procedures(During procedure)