Application of CO2 Insufflations in Colonoscopy Randomized Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00745927
First received: August 31, 2008
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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 Intervention
Colorectal Neoplasm
Colorectal Cancer
Other: CO2 insufflations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Application of CO2 Insufflations in Colonoscopy Examination-A Single-blinded Randomized Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Degree of abdominal discomfort during and after colonoscopy [ Time Frame: 0, 2, 8-10 hr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of neoplasm detected [ Time Frame: At the time of colonoscopy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who receive Screening colonoscopy or secondary colonoscopy

Exclusion Criteria:

  • Subjects who have COPD or cardiovascular diseases
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745927

Contacts
Contact: Han-Mo Chiu, M.D 886-2-23123456 ext 63354 hanmochiu@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Han-Mo Chiu, MD    886-2-23123456 ext 63354    hanmochiu@ntu.edu.tw   
Principal Investigator: Han-Mo Chiu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Hsiu-Po Wang, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00745927     History of Changes
Other Study ID Numbers: 200802031R
Study First Received: August 31, 2008
Last Updated: August 13, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014