Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy
Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial
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.
研究概览
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Shaanxi
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Xi'an、Shaanxi、中国、710032
- Endoscopic center, Xijing Hospital of Digestive Diseases
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Female patients with BMI < 20
Exclusion Criteria:
- History of colorectal surgery
- Severe colonic stricture or obstructing tumor
- Patients who cannot give informed consent and those who are hemodynamically unstable
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:空气结肠镜检查
结肠镜检查将在不使用药物的情况下进行,并在插入结肠镜期间明智地吹气。
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其他:水结肠镜检查
结肠镜检查将在没有药物的情况下进行,并在插入结肠镜期间通过注水代替吹气来辅助。
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结肠镜检查将在没有药物的情况下进行,并在插入结肠镜期间通过注水代替吹气来辅助。
输液包括将温热的无菌水注入结肠以打开结肠以推进结肠镜直到到达结肠末端(盲肠)。
水通过装有脚踏开关的输液泵通过内窥镜冲洗通道输送,该脚踏开关由内窥镜医师控制。
用于清洁残留粪便的注入水将根据需要抽吸以清洁结肠腔。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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盲肠插管成功率
大体时间:最多两年
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将结肠镜插入盲肠
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最多两年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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腺瘤检出率
大体时间:最多两年
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每组中至少有一个腺瘤的参与者比例
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最多两年
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视觉模拟量表上的疼痛评分
大体时间:最多两年
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0 = 没有疼痛,到 10 = 最剧烈的疼痛
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最多两年
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盲肠插管时间
大体时间:最多两年
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结肠镜插管从肛门到盲肠的总时间
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最多两年
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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