Application of CO2 Insufflations in Colonoscopy Randomized Trial

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. Identifier: NCT00745927
Recruitment Status : Unknown
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 3, 2008
Last Update Posted : August 14, 2012
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, because of a lack of suitable equipment and continued technical improvement in colonoscopy.

In laparoscopic surgery, CO2 insufflation is widely applied and safely used with the patient under general anesthesia. CO2 insufflation is also applied for CT colonography for reduction of discomfort during or after procedure.2 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.6 Screening colonoscopy, which can be completed within 15 minutes if no lesion being 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. With application of CO2 insufflation, further improvement of patient compliance can be anticipated.

This study aims to investigate whether use of CO2 insufflations can reduce examinee discomfort in comparison with air.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Colorectal Cancer Other: CO2 insufflations Not Applicable

Detailed Description:
  • Setting: Screening colonoscopy or secondary colonoscopy after positive FOBT performed in endoscopic unit of a single university hospital
  • Study design: Single blinded randomized trial
  • Randomization process: sealed envelope
  • Study subjects:

Inclusion criteria: Subjects who receive Screening colonoscopy or secondary colonoscopy Exclusion criteria: subjects who have COPD or cardiovascular diseases

  • Study duration: June 2008 to November 2012
  • Post-colonoscopy discomfort will be measured and obtained from the screenee at several time points using visual analogue pain scoring system:

    • Immediately after colonoscopy for non-sedated patients, immediately after awaken from sedation for sedated patients
    • 2 hrs after colonoscopy
    • 8-12 hours after colonoscopy
  • Statistical analysis:

    • Sample size estimation: according to our previous unpublished data using air insufflations at colonoscopy, mean pain score was 3 and standard deviation was 2.38. Assuming 15% difference of discomfort, sample size up to 171 are required for each group (CO2 vs. air, sedated and non-sedated) in this study. (2 sided test, α=0.05, power=80%)
    • Student t-test for pain score comparison
    • Ancillary analysis: pCO2, sedation drug dosage, and procedural time in both groups. For TCCO2 comparison, ANOVA for repeated measurement will be used. For variables not normally distributed, Wilcoxon rank sum test wall be used as a supplementary analysis.
    • SAS statistical program, version 9.0 (SAS institute Inc., Cary, NC) will be used for all statistical analysis

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Application of CO2 Insufflations in Colonoscopy Examination-A Single-blinded Randomized Trial
Study Start Date : June 2008
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Room air insufflations
Room air will be used for insufflations during colonoscopy
Active Comparator: CO2 insufflations
CO2 will be used for insufflations during colonoscopy
Other: CO2 insufflations
CO2 insufflations during whole procedure of colonoscopy

Primary Outcome Measures :
  1. Degree of abdominal discomfort during and after colonoscopy [ Time Frame: 0, 2, 8-10 hr ]

Secondary Outcome Measures :
  1. Number of neoplasm detected [ Time Frame: At the time of colonoscopy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects who receive Screening colonoscopy or secondary colonoscopy

Exclusion Criteria:

  • Subjects who have COPD 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 identifier (NCT number): NCT00745927

Contact: Han-Mo Chiu, M.D 886-2-23123456 ext 63354

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Han-Mo Chiu, MD    886-2-23123456 ext 63354   
Principal Investigator: Han-Mo Chiu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Study Director: Hsiu-Po Wang, MD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT00745927     History of Changes
Other Study ID Numbers: 200802031R
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Keywords provided by National Taiwan University Hospital:
Colorectal neoplasm
Colorectal cancer
Screening colonoscopy
CO2 insufflations

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases