Application of CO2 Insufflations in Colonoscopy Randomized Trial

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Colorectal Neoplasm
• Intervention / Treatment: Other: CO2 insufflations

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
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Han-Mo Chiu, M.D; Phone Number: 63354 886-2-23123456; Email: hanmochiu@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Han-Mo Chiu, MD; Phone Number: 63354 886-2-23123456; Email: hanmochiu@ntu.edu.tw
    • Principal Investigator: Han-Mo Chiu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who receive Screening colonoscopy or secondary colonoscopy

Exclusion Criteria:

• Subjects who have COPD or cardiovascular diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Degree of abdominal discomfort during and after colonoscopy	0, 2, 8-10 hr

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of neoplasm detected	At the time of colonoscopy

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Hsiu-Po Wang, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: August 31, 2008
• First Submitted That Met QC Criteria: September 2, 2008
• First Posted (Estimate): September 3, 2008

Study Record Updates

• Last Update Posted (Estimate): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 13, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colonoscopy; Screening colonoscopy; Colorectal neoplasm; CO2 insufflations
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 200802031R