Comparative Efficacy of Water & Indigo Carmine vs Water or Air Method
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate
研究概览
简要总结
Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal cancer screening. Population studies have shown that traditional air colonoscopy fails to eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The investigators aim to establish the superior effectiveness of combining chromoendoscopy with the water exchange method in detecting more proximal diminutive adenomas during screening colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical colonoscopy will minimize the risk of missed lesions. The improvement may translate into a remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher adenoma detection rate may minimize the burden of post screening colonoscopy interval colorectal cancers among the veteran population.
详细描述
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Design: Prospective, single center, patient blinded, randomized controlled trial
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Methods: Colonoscopy with traditional air insufflation, water exchange or water exchange plus indigocarmine to aid insertion of colonoscope; split dose bowel preparation; all patients will receive sedation; assessment of serum electrolytes level before and after colonoscopy
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Control method: Traditional air insufflation method.
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Study methods:
- Water exchange method.
- Water method combined with chromoendoscopy (0.008% indigo carmine).
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Population to be studied Veterans between age 50 and 75 referred for first time screening colonoscopy
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Unit(s) of analysis
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Primary outcome: overall adenoma detection rate.
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Secondary outcomes: patient demographic variable and procedure related measures.
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Sampling strategy: all Veterans referred for screening colonoscopy will be offered enrollment in the study.
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Sample size calculation. A total of 480 subjects will be recruited and randomized with 160 in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •asymptomatic Veterans scheduled for first time screening colonoscopy and agree to be randomized will be enrolled.
排除标准
- •patients who decline to be randomized, non screening cases.
研究组 & 干预措施
water (exchange) method
Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.
干预措施: water (exchange) method (Procedure)
water (exchange) plus dye method
Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions
干预措施: Indigo carmine (Drug)
water (exchange) plus dye method
Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions
干预措施: water (exchange) plus dye method (Procedure)
air method
The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.
干预措施: air method (Procedure)
结局指标
主要结局
Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate
时间窗: 36 months
Proximal diminutive adenoma detection rate (ADR) in screening colonoscopy performed with the unusual air method, versus the water (exchange) method and with dye added to the water (exchange) method
次要结局
未报告次要终点