OutpatientsNCT01415076
The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
A study testing Insufflation with CO2 in people with Outpatients, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Outpatients
- What is being tested?
- Insufflation with CO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Jun 2011
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with an appropriate indication for colonoscopy were considered eligible.
Who cannot join
- Exclusion criteria included severe hematochezia, acute colonic pseudo-obstruction, known obstructive lesions, age <18 years, prior colon resection, fulminant colitis, chronic obstructive pulmonary disease requiring oxygen, and a medical history of CO2 retention. Patients that required only a partial colonoscopy or were unable to read or understand Chinese were also excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Gastroenterology, Tri-Service General Hospital
Taipei, 114
About this study
Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. The aims of the study were to evaluate the timing of administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.
- Conditions
- Outpatients
- Being tested
- Insufflation with CO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insufflation with CO2Procedure or surgery
Also called the Olympus UCR Endoscopic CO2 Regulation Unit
Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
| Study group | Role | What they receive |
|---|---|---|
| Insertion without CO2 insufflation | Placebo comparator | Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list. Receives: Procedure: Insufflation with CO2 |
| Insertion with CO2 | Experimental | Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list. Receives: Procedure: Insufflation with CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal pain during and after colonoscopy
Pain was recorded on a ten-point visual analog scale (0- no pain, 10- worst imaginable pain) at left-sided colonoscopic insertion, right-sided colonoscopic insertion, and at 1, 3, 6, and 24 hours postprocedure.
Measured: One day
Secondary outcomes (4)
delayed bleeding
Measured: One day
colonoscopic cecal intubation time
Measured: One day
completeness of intubation
Measured: One day
loop formation
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutpatientsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng-Jen Chen, Tri-Service General Hospital (TSGH)
- Investigators
- Tsai-Yuan Hsieh, MD.PhD, Study chair, Division of Gastroenterology, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415076
- Sponsor's protocol ID
- TSGH-C99-062
- Status last verified
- Sep 2012
- First submitted
- 10 Aug 2011
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
- ClinicalTrials.gov ID
- NCT01415076
- Acronym / sponsor ID
- TSGH-C99-062
- Conditions
- Outpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2011 (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.
Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. The aims of the study were to evaluate the timing of administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insertion without CO2 insufflation | Placebo comparator | Procedure: Insufflation with CO2Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list. |
| Insertion with CO2 | Experimental | Procedure: Insufflation with CO2Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with an appropriate indication for colonoscopy were considered eligible.
Key exclusion criteria (1 listed)
- Exclusion criteria included severe hematochezia, acute colonic pseudo-obstruction, known obstructive lesions, age <18 years, prior colon resection, fulminant colitis, chronic obstructive pulmonary disease requiring oxygen, and a medical history of CO2 retention. Patients that required only a partial colonoscopy or were unable to read or understand Chinese were also excluded.
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 |
|---|---|---|
| Insufflation with CO2Also: the Olympus UCR Endoscopic CO2 Regulation UnitPatients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list. | Procedure or surgery | Insertion with CO2, Insertion without CO2 insufflation |
Primary outcome
abdominal pain during and after colonoscopy
Time frame: One day
Pain was recorded on a ten-point visual analog scale (0- no pain, 10- worst imaginable pain) at left-sided colonoscopic insertion, right-sided colonoscopic insertion, and at 1, 3, 6, and 24 hours postprocedure.
4 secondary outcomes
delayed bleeding
Time frame: One day
colonoscopic cecal intubation time
Time frame: One day
completeness of intubation
Time frame: One day
loop formation
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
Tsai-Yuan Hsieh, MD.PhD study chair
Division of Gastroenterology, Tri-Service General 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 Insufflation with CO2 in people with Outpatients, run by Tri-Service General Hospital (TSGH) 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: finished, as of the sponsor's last update on 5 Sep 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abdominal pain during and after colonoscopy (time frame: One day). 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 5 Sep 2012.