ColonoscopyWater/CO2NCT01440543
Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy
A study testing Water immersion insertion AND CO2 insufflation, Water immersion insertion and CO2 insufflation in people with Colonoscopy, run by Vitkovice Hospital at 1 site in Czechia.
Trial summary
Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Water immersion insertion AND CO2 insufflation, Water immersion insertion and CO2 insufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- men and women older than 18 years referred for diagnostic outpatient colonoscopy
- provided written consent
Who cannot join
- history of colorectal surgery
- known diagnosis of inflammatory bowel disease
- chronic benzodiazepine use
- refusal of minimal sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.
This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).
- Conditions
- Colonoscopy
- Being tested
- Water immersion insertion AND CO2 insufflation, Water immersion insertion, CO2 insufflation
- Keywords
- colonoscopy, water immersion, CO2 insufflation, patients referred for diagnostic outpatient colonoscopy, (screening, surveillance, symptoms), patient discomfort associated with diagnostic colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water immersion insertion AND CO2 insufflationProcedure or surgery
- room temperature water infused by water pump into the colon just to facilitate scope insertion
- CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection
Water immersion insertionProcedure or surgery
- room temperature water infused by water pump into the colon just to facilitate scope insertion
- standard room air insufflation during colonoscope withdrawal and mucosal inspection
CO2 insufflationProcedure or surgery
- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Water/CO2 | Experimental | water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal Receives: Procedure: Water immersion insertion AND CO2 insufflation |
| Water/Air | Experimental | Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal Receives: Procedure: Water immersion insertion |
| CO2/CO2 | Experimental | CO2 insufflation during both colonoscope insertion and withdrawal Receives: Procedure: CO2 insufflation |
| Air/Air | No intervention | room air insufflation during both colonoscope insertion and withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Minimal Sedation Colonoscopy
Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.
Measured: six months
Success Rate of Minimal Sedation Colonoscopy
A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.
Measured: 6 months
Secondary outcomes (1)
Patient Comfort During the Procedure and During First 24 Hours After Procedure
Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitkovice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premysl Falt MD, Vitkovice Hospital
- Investigators
- Premysl Falt, MD, Principal investigator, Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440543
- Sponsor's protocol ID
- DDC VN 01
- Acronym
- Water/CO2
- Status last verified
- Dec 2012
- First submitted
- 19 Sep 2011
- Last updated
- 28 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
PubMed 22569079
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
- ClinicalTrials.gov ID
- NCT01440543
- Acronym / sponsor ID
- Water/CO2 / DDC VN 01
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, water immersion, CO2 insufflation, patients referred for diagnostic outpatient colonoscopy, (screening, surveillance, symptoms), patient discomfort associated with diagnostic colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Vitkovice HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Posted 28 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.
This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Water/CO2 | Experimental | Procedure: Water immersion insertion AND CO2 insufflationwater immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal |
| Water/Air | Experimental | Procedure: Water immersion insertionWater immersion during colonoscope insertion and air insufflation during colonoscope withdrawal |
| CO2/CO2 | Experimental | Procedure: CO2 insufflationCO2 insufflation during both colonoscope insertion and withdrawal |
| Air/Air | No intervention | –room air insufflation during both colonoscope insertion and withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men and women older than 18 years referred for diagnostic outpatient colonoscopy
- provided written consent
Key exclusion criteria (4 listed)
- history of colorectal surgery
- known diagnosis of inflammatory bowel disease
- chronic benzodiazepine use
- refusal of minimal sedation
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 |
|---|---|---|
| Water immersion insertion AND CO2 insufflation* room temperature water infused by water pump into the colon just to facilitate scope insertion * CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection | Procedure or surgery | Water/CO2 |
| Water immersion insertion* room temperature water infused by water pump into the colon just to facilitate scope insertion * standard room air insufflation during colonoscope withdrawal and mucosal inspection | Procedure or surgery | Water/Air |
| CO2 insufflation- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal | Procedure or surgery | CO2/CO2 |
Primary outcome
Success Rate of Minimal Sedation Colonoscopy
Time frame: six months
Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.
Success Rate of Minimal Sedation Colonoscopy
Time frame: 6 months
A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.
1 secondary outcome
Patient Comfort During the Procedure and During First 24 Hours After Procedure
Time frame: six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22569079Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
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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.
Premysl Falt, MD principal investigator
Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water immersion insertion AND CO2 insufflation, Water immersion insertion and CO2 insufflation in people with Colonoscopy, run by Vitkovice Hospital at 1 site in Czechia.
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 28 Jan 2013. 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 Czechia. 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?
Yes. Results are posted in the registry (first posted 28 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Success Rate of Minimal Sedation Colonoscopy (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01440543, which also lists 1 linked publication.
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 28 Jan 2013.