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临床试验/NCT01807312
NCT01807312已完成不适用

The Application of CO2 Insufflations in Routine Colonoscopy Examination for Duration in Toilet After Examination Compared With Air Insufflations

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
The number of times and duration in the toilet of the patient after colonoscopy examination

研究概览

简要总结

It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, due a lack of suitable replacement of equipment or technical improvement in colonoscopy.

The investigators use radio frequency identification (RFID) technology to record the number of times and duration in the toilet of the patient after colonoscopy examination. These data may be proxies for discomfort. With application of CO2 insufflation, the times and duration in the toilet after examination will decrease as well as patient's discomfort after procedure, and further improvement of patient compliance can be anticipated.

详细描述

It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, due a lack of suitable replacement of equipment or technical improvement in colonoscopy.

In laparoscopic surgery, CO2 insufflation is widely applied and safely used for patients under general anesthesia. CO2 insufflation is also applied in CT colonography for reduction of discomfort during or after procedure. During endoscopic procedure for colorectal neoplasia resection, however, long procedural time may increase not only the degree of discomfort during and after the procedure but also the risk of perforation. In addition to laparoscopic surgery, CO2 insufflation has also been applied to other endoscopic procedures. Saito et al reported the application of CO2 insufflation in endoscopic submucosal dissection (ESD) of colorectal neoplasia in a prospective study in which their average procedural time using CO2 insufflation was 90 minutes under conscious sedation with average of 5.6 mg of midazolam. When compared with control group using room air, statistically negligible difference of pCO2 was observed with significant difference in abdominal discomfort. Screening colonoscopy, which can be completed within 15 minutes if no lesion has been detected, requires high screenee satisfaction so as to improve patient compliance. In the setting of colonoscopy after positive FOBT, the attendance rate for secondary colonoscopy was around 60 to 70 % according to the data demonstrated in previous RCT and population-based studies.

Recently, radio frequency identification (RFID) technology, a 'wireless automatic identification and data capture (AIDC) technology has emerged as a multidimensional innovation that can accelerate the transformation of healthcare processes. The effective adoption and use of RFID technology is expected to transform intra- and inter-organisational business processes, thus allowing intra- and inter-firms business process innovation, real-time data collection and sharing at the supply chain level, business analytics and improved decision making. In the specific context of the healthcare sector, RFID technology offers a better means for patient identification, tracking, and tracing.We use radio frequency identification (RFID) technology to record the number of times and duration in the toilet of the patient after colonoscopy examination. These data may be proxies for discomfort. With application of CO2 insufflation, the times and duration in the toilet after examination will decrease as well as patient's discomfort after procedure, and further improvement of patient compliance can be anticipated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The number of times and duration in the toilet of the patient after colonoscopy examination

时间窗: Two hours after examination

次要结局

  • the point of pain scoring system after colonoscopy examination(Two hours after examination)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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