Application of CO2 Insufflations in Colonoscopy Randomized Trial - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00745927

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.1 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. 1, 3-5 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 during colonoscopy

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Application of CO2 Insufflations in Colonoscopy Examination-A Single-Blinded Randomized Trial

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:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Air insufflations used in colonoscopy: room air
2: Active Comparator Air insufflations used in colonoscopy: CO2	Other: CO2 insufflations during colonoscopy 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 December 2008
In extended pilot study, pCO2 will be monitored using percutaneous monitoring system (TCM4 TC-CO2/O2 device, Radiometer, Copenhagen, Denmark) during colonoscopy with CO2 insufflation under the assistance of anesthesiologist. Measurement of TcCO2 by percutaneous monitoring system has been reported to have good correlation with pCO2 obtained via arterial line.
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) 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

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

Responsible Party:	National Taiwan Univesity Hospital ( Han-Mo Chiu )
Study ID Numbers:	200802031R
Study First Received:	August 31, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745927
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Colorectal neoplasm
Colorectal cancer
Screening colonoscopy
CO2 insufflations
Colonoscopy

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009