Application of CO2 Insufflations in Colonoscopy Randomized Trial

Colorectal Cancer Clinical Trial

Official title:

Application of CO2 Insufflations in Colonoscopy Examination-A Single-blinded Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00745927
• Other study ID #: 200802031R
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2008
• Last updated: August 13, 2012
• Start date: June 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: National Taiwan University Hospital
• Contact: Han-Mo Chiu, M.D
• Phone: 886-2-23123456
• Email: hanmochiu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects who receive Screening colonoscopy or secondary colonoscopy

Exclusion Criteria:

• Subjects who have COPD or cardiovascular diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Other:
• CO2 insufflations
CO2 insufflations during whole procedure of colonoscopy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of abdominal discomfort during and after colonoscopy		0, 2, 8-10 hr	Yes
Secondary	Number of neoplasm detected		At the time of colonoscopy	Yes