Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01807312
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Carbon Dioxide Insufflation Device: Endoscopic CO2 regulation unit and accessories Device: Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CO2 insufflation
CO2 insufflations was applicated in routine colonoscopy examination with Endoscopic CO2 regulation unit and accessories
Device: Endoscopic CO2 regulation unit and accessories
Olympus UCR Endoscopic CO2 Regulation Unit

Placebo Comparator: Air insufflation
Air insufflations is applicated in Routine Colonoscopy Examination
Device: Placebo



Primary Outcome Measures :
  1. The number of times and duration in the toilet of the patient after colonoscopy examination [ Time Frame: Two hours after examination ]

Secondary Outcome Measures :
  1. the point of pain scoring system after colonoscopy examination [ Time Frame: Two hours after examination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Subjects aged between 20 and 80 years who receive Screening colonoscopy

Exclusion criteria:

  • Subjects who have chronic lung diseases or cardiovascular diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807312


Locations
Layout table for location information
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Han-Mo Chiu, PhD Department of Internal Medicine, National Taiwan University Hospital

Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01807312     History of Changes
Other Study ID Numbers: 201211070RIC
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013

Keywords provided by National Taiwan University Hospital:
colonoscopy