Clinical trial NCT00745927: Application of CO2 Insufflations in Colonoscopy Randomized Trial
Official title: Application of CO2 Insufflations in Colonoscopy Examination-A Single-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasm
Colorectal Cancer
Keywords: Colorectal neoplasm
Colorectal cancer
Screening colonoscopy
CO2 insufflations
Colonoscopy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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 criteria: Inclusion Criteria:

* Subjects who receive Screening colonoscopy or secondary colonoscopy

Exclusion Criteria:

* Subjects who have COPD or cardiovascular diseases

Primary outcomes:
measure: Degree of abdominal discomfort during and after colonoscopy
timeFrame: 0, 2, 8-10 hr
Secondary outcomes:
measure: Number of neoplasm detected
timeFrame: At the time of colonoscopy
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hsiu-Po Wang, MD
role: STUDY_DIRECTOR
References: