PainPhase 3COCENCT01450202
Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients
A Phase 3 study testing bowel insufflation gas in people with Pain, run by Inje University at 1 site in South Korea.
Trial summary
Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- bowel insufflation gas
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jan 2012
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD
Who cannot join
- age < 18 or > 70 years
- pregnancy
- breast feeding
- chronic obstructive lung disease (COPD)
- known CO2 retention and refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial
Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy.
The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.
- Conditions
- Pain
- Being tested
- bowel insufflation gas
- Keywords
- Carbon dioxide insufflation, Colonoscopy, Esophagogastroduodenoscopy, Bowel insufflation, Postprocedure pain, Pain Due to Certain Specified Procedures
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel insufflation gasOther
air insufflation, during colonoscopy and esophagogastroduodenoscopy
bowel insufflation gasOther
CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy
| Study group | Role | What they receive |
|---|---|---|
| Air insufflation, colonoscopy, esophagogastroduodenoscopy | Placebo comparator | Not described Receives: Other: bowel insufflation gas |
| CO2 insufflation, colonoscopy, esophagogastroduodenoscopy | Active comparator | Not described Receives: Other: bowel insufflation gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-procedural pain
The primary end point of the study was to assess post-procedural pain according to VAS scale
Measured: 3 months
Secondary outcomes (2)
abdominal distention
abdominal distention using measurement of patient waist circumferences
Measured: 3 months
ETCO2
Measure ETCO2 using nasal cannula
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Hee Seo, MD, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450202
- Sponsor's protocol ID
- Oct 2011-01
- Acronym
- COCE
- Status last verified
- Jun 2012
- First submitted
- 4 Oct 2011
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT01450202
- Acronym / sponsor ID
- COCE / Oct 2011-01
- Conditions
- Pain
- Keywords
- Carbon dioxide insufflation, Colonoscopy, Esophagogastroduodenoscopy, Bowel insufflation, Postprocedure pain, Pain Due to Certain Specified Procedures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Oct 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.
Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy.
The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air insufflation, colonoscopy, esophagogastroduodenoscopy | Placebo comparator | Other: bowel insufflation gas |
| CO2 insufflation, colonoscopy, esophagogastroduodenoscopy | Active comparator | Other: bowel insufflation gas |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD
Key exclusion criteria (5 listed)
- age < 18 or > 70 years
- pregnancy
- breast feeding
- chronic obstructive lung disease (COPD)
- known CO2 retention and refusal to participate in the study
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 |
|---|---|---|
| bowel insufflation gasair insufflation, during colonoscopy and esophagogastroduodenoscopy | Other | Air insufflation, colonoscopy, esophagogastroduodenoscopy |
| bowel insufflation gasCO2 insufflation, during colonoscopy and esophagogastroduodenoscopy | Other | CO2 insufflation, colonoscopy, esophagogastroduodenoscopy |
Primary outcome
post-procedural pain
Time frame: 3 months
The primary end point of the study was to assess post-procedural pain according to VAS scale
2 secondary outcomes
abdominal distention
Time frame: 3 months
ETCO2
Time frame: 3 months
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 26 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bowel insufflation gas in people with Pain, run by Inje University at 1 site in South Korea.
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 5 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 26 Jun 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
post-procedural pain (time frame: 3 months). 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 26 Jun 2012.