Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Cecal intubation success rate
研究概览
简要总结
Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.
Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in low-BMI female patients.
The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with BMI < 20
排除标准
- •History of colorectal surgery
- •Severe colonic stricture or obstructing tumor
- •Patients who cannot give informed consent and those who are hemodynamically unstable
结局指标
主要结局
Cecal intubation success rate
时间窗: up to two years
Insertion of a colonoscope to the cecum
次要结局
- Adenoma detection rate(up to two years)
- Cecum intubation time(up to two years)
- Pain Scores on the Visual Analog Scale(up to two years)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China
