Colorectal NeoplasmNCT00745927
Application of CO2 Insufflations in Colonoscopy Randomized Trial
A study testing CO2 insufflations in people with Colorectal Neoplasm and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasm, Colorectal Cancer
- What is being tested?
- CO2 insufflations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who receive Screening colonoscopy or secondary colonoscopy
Who cannot join
- Subjects who have COPD or cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Han-Mo Chiu, MD, 886-2-23123456 ext. 63354, hanmochiu@ntu.edu.tw
Han-Mo Chiu, MD
About this study
Official title: 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.
Read the 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
- Conditions
- Colorectal Neoplasm, Colorectal Cancer
- Being tested
- CO2 insufflations
- Keywords
- Colorectal neoplasm, Colorectal cancer, Screening colonoscopy, CO2 insufflations, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 insufflationsOther
CO2 insufflations during whole procedure of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Room air insufflations | No intervention | Room air will be used for insufflations during colonoscopy |
| CO2 insufflations | Active comparator | CO2 will be used for insufflations during colonoscopy Receives: Other: CO2 insufflations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of abdominal discomfort during and after colonoscopy
Measured: 0, 2, 8-10 hr
Secondary outcomes (1)
Number of neoplasm detected
Measured: At the time of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Hsiu-Po Wang, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745927
- Sponsor's protocol ID
- 200802031R
- Status last verified
- Aug 2012
- First submitted
- 31 Aug 2008
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of CO2 Insufflations in Colonoscopy Examination-A Single-blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT00745927
- Acronym / sponsor ID
- 200802031R
- Conditions
- Colorectal Neoplasm, Colorectal Cancer
- Keywords
- Colorectal neoplasm, Colorectal cancer, Screening colonoscopy, CO2 insufflations, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Room air insufflations | No intervention | –Room air will be used for insufflations during colonoscopy |
| CO2 insufflations | Active comparator | Other: CO2 insufflationsCO2 will be used for insufflations during colonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who receive Screening colonoscopy or secondary colonoscopy
Key exclusion criteria (1 listed)
- Subjects who have COPD or cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 insufflationsCO2 insufflations during whole procedure of colonoscopy | Other | CO2 insufflations |
Primary outcome
Degree of abdominal discomfort during and after colonoscopy
Time frame: 0, 2, 8-10 hr
1 secondary outcome
Number of neoplasm detected
Time frame: At the time of colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiu-Po Wang, MD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 insufflations in people with Colorectal Neoplasm and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-Mo Chiu, M.D (886-2-23123456 ext. 63354, hanmochiu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of abdominal discomfort during and after colonoscopy (time frame: 0, 2, 8-10 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.