Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study
研究概览
详细说明
For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.
For the AI method, water was not used, and air was insufflated during insertion.
Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).
研究类型
注册 (预期的)
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
- 招聘中
- Endoscopic center, Xijing Hospital of Digestive Diseases
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接触：
- Gui Ren, MD
- 电话号码：+862984771536
- 邮箱：renguigz@hotmail.com
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首席研究员：
- Gui Ren, MD
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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:
- Age 18-80 patients undergoing selective polypectomy
Exclusion Criteria:
- Polyps found more than 6 months
- Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
- Patients with history of inflammatory bowel disease
- Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
- Patients not undergoing standard bowel preparation
- Patients with solid feces in the last stool after bowel preparation
- Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
- Hemodynamically unstable
- Pregnant women
- Unable to provide informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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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实验性的：Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum.
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Water exchange (WE) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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有源比较器：Air insufflation (AI) method
Air insufflation (AI) method was used for insertion to the cecum.
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Air insufflation (AI) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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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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Adenoma miss rate
大体时间：12 months
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Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.
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12 months
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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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adenoma-level miss rate
大体时间：12 months
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Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.
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12 months
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Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy
大体时间：12 months
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Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
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12 months
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Adenoma per positive patient (APP)
大体时间：12 months
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The mean number of adenoma per positive patient
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12 months
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Quality of Bowel Preparation
大体时间：12 months
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The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
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12 months
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Complication rate
大体时间：12 months
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Bleeding, perforation and others
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12 months
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Pain Scores on the Visual Analog Scale compared with previous colonoscopy
大体时间：12 months
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0 = no pain, to 10 = most severe pain
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12 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.
- Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Gut. 2016 Mar;65(3):374-89. doi: 10.1136/gutjnl-2015-311110.
- Ren G, Wang X, Luo H, Yao S, Liang S, Zhang L, Dong T, Chen L, Tao Q, Guo X, Han Y, Pan Y. Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial. Dig Liver Dis. 2021 May;53(5):625-630. doi: 10.1016/j.dld.2020.11.012. Epub 2020 Dec 31.
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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