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临床试验/NCT01383252
NCT01383252已完成不适用

Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

VA Northern California Health Care System1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Success of colonoscopy

研究概览

简要总结

In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:

  1. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
  2. Study method improves bowel preparation and increases polyp pickup rate

详细描述

Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.

The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.

In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult (>50 years old)
  • •Male and female patients
  • •Scheduled and consented for screening or surveillance colonoscopy without medications
  • •Accept randomization to the study or the conventional method
  • •Agree to complete study questionnaires
  • •The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.

排除标准

  • •Patients who decline to participate
  • •Unable to give informed consent or complete the questionnaires due to language or other difficulties

研究组 & 干预措施

Water method

Experimental

Water infusion in lieu of air insufflation for screening and surveillance colonoscopy

干预措施: Water infusion in lieu of air insufflation (Procedure)

Air method

Active Comparator

Air insufflation for screening and surveillance colonoscopy

干预措施: Air method (Procedure)

结局指标

主要结局

Success of colonoscopy

时间窗: 24 months

successful cecal intubation

次要结局

  • Polyp detection(24 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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