The Application of CO2 Insufflations in Routine Colonoscopy Examination for Duration in Toilet After Examination Compared With Air Insufflations
Condition: Carbon Dioxide Insufflation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Endoscopic CO2 regulation unit and accessories; Placebo
Intervention type(s): Device; Device
Intervention description(s): Olympus UCR Endoscopic CO2 Regulation Unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: colonoscopy