ColonoscopyNCT03141697
The Use of CO2 in Routine-Colonoscopy
A study testing Carbon Dioxide and Room air in people with Colonoscopy, run by University of Leipzig at 1 site in Germany.
Trial summary
In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Carbon Dioxide and Room air
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2012to 31 Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years
- informed consent
Who cannot join
- former colonic resections
- severe heart or lung disease (NYHA III or IV)
- Pregnancy
- Patients with planned gastroscopy within 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is CO2 Insufflation an Amelioration of Routine Colonoscopy?
In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out questionnaires to record pain, abdominal bloating and flatulence.
Read the detailed description
Between April 2012 and August 2014 150 patients referred to the University Hospital of Leipzig for colonoscopy were randomly assigned to either CO2 or air insufflation.
All examinations were performed by one of four experienced endoscopists. The patients usually received sedation. For sedation midazolam and propofol was used. At the beginning of the examination the patients usually received between 3-5 mg of midazolam and 20-40 mg propofol. During endoscopy propofol was titrated by administration of 20 mg at the time according to and pain reaction of the patient and required depth of sedation.
All patients had nasal insufflation of oxygen with 2 litres per minute. All sedated patients were monitored for pulse, blood pressure and blood oxygen saturation.
For bowel cleansing a solution of Macrogol 3350 (Moviprep®, Norgine) was administered orally according to the manufacturer.
All colonoscopies were performed using Fujifilm Endoscopes (EC 590 Series). For examinations with use of carbon dioxide the Fujifilm CO2 Insufflator GW-1 was used with appropriate water bottle and endoscope valve. The air pump of the light source Fujifilm System 4400 was deactivated according to the manufacturer.
- Conditions
- Colonoscopy
- Being tested
- Carbon Dioxide, Room air
- Keywords
- Carbon Dioxide, Coloboscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon DioxideDevice
Insufflation of Carbon Dioxide
Room airDevice
Insufflation of room air
| Study group | Role | What they receive |
|---|---|---|
| Carbon Dioxide | Experimental | Colonoscopy with Insufflation of Carbon Dioxide Receives: Device: Carbon Dioxide |
| Room Air | Placebo comparator | Colonoscopy with Insufflatioin of Room Air Receives: Device: Room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-procedural pain
Pain after Colonoscopy, assessed by visual analog scale (VAS)
Measured: 0 - 24 hrs after colonoscopy
Secondary outcomes (4)
Abdominal bloating
Abdominal bloating, assessed by questionaire
Measured: 0 - 24 hrs after colonoscopy
flatulence
flatulence, assessed by questionaire
Measured: 0 - 24 hrs after colonoscopy
procedure time
time used for colonoscopy
Measured: duration of colonoscopy
Used amount of sedative drugs
Amount of midazolam and propofol administrated during colonoscopy
Measured: during endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Apr 2012
- Primary completion31 Aug 2014
- Study completion31 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Feisthammel, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141697
- Sponsor's protocol ID
- CO2 Colonoscopy
- Status last verified
- May 2017
- First submitted
- 26 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is CO2 Insufflation an Amelioration of Routine Colonoscopy?
- ClinicalTrials.gov ID
- NCT03141697
- Acronym / sponsor ID
- CO2 Colonoscopy
- Conditions
- Colonoscopy
- Keywords
- Carbon Dioxide, Coloboscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out questionnaires to record pain, abdominal bloating and flatulence.
Detailed description
Between April 2012 and August 2014 150 patients referred to the University Hospital of Leipzig for colonoscopy were randomly assigned to either CO2 or air insufflation.
All examinations were performed by one of four experienced endoscopists. The patients usually received sedation. For sedation midazolam and propofol was used. At the beginning of the examination the patients usually received between 3-5 mg of midazolam and 20-40 mg propofol. During endoscopy propofol was titrated by administration of 20 mg at the time according to and pain reaction of the patient and required depth of sedation.
All patients had nasal insufflation of oxygen with 2 litres per minute. All sedated patients were monitored for pulse, blood pressure and blood oxygen saturation.
For bowel cleansing a solution of Macrogol 3350 (Moviprep®, Norgine) was administered orally according to the manufacturer.
All colonoscopies were performed using Fujifilm Endoscopes (EC 590 Series). For examinations with use of carbon dioxide the Fujifilm CO2 Insufflator GW-1 was used with appropriate water bottle and endoscope valve. The air pump of the light source Fujifilm System 4400 was deactivated according to the manufacturer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon Dioxide | Experimental | Device: Carbon DioxideColonoscopy with Insufflation of Carbon Dioxide |
| Room Air | Placebo comparator | Device: Room airColonoscopy with Insufflatioin of Room Air |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18 years
- informed consent
Key exclusion criteria (4 listed)
- former colonic resections
- severe heart or lung disease (NYHA III or IV)
- Pregnancy
- Patients with planned gastroscopy within 24 hours
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 |
|---|---|---|
| Carbon DioxideInsufflation of Carbon Dioxide | Device | Carbon Dioxide |
| Room airInsufflation of room air | Device | Room Air |
Primary outcome
Post-procedural pain
Time frame: 0 - 24 hrs after colonoscopy
Pain after Colonoscopy, assessed by visual analog scale (VAS)
4 secondary outcomes
Abdominal bloating
Time frame: 0 - 24 hrs after colonoscopy
flatulence
Time frame: 0 - 24 hrs after colonoscopy
procedure time
Time frame: duration of colonoscopy
Used amount of sedative drugs
Time frame: during endoscopy
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 May 2017.
- Individual participant dataSharing planned: Undecided
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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 study testing Carbon Dioxide and Room air in people with Colonoscopy, run by University of Leipzig at 1 site in Germany.
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 2 inclusion and 4 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 May 2017. 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 Germany. 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?
Post-procedural pain (time frame: 0 - 24 hrs after colonoscopy). 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 May 2017; AzTrials last refreshed its copy on 2 Nov 2026.