Warm WaterNCT01259583
Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy
A study testing CO2 and Warm water in people with Warm Water and CO2 Colonoscopy, run by Valduce Hospital at 1 site in Italy.
Trial summary
Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Warm Water, CO2 Colonoscopy, Unsedated Colonoscopy
- What is being tested?
- CO2 and Warm water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2010to Dec 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult outpatients willing to undergo colonoscopy without routine initial sedation
Who cannot join
- refuse to initiate colonoscopy without routine sedation
- inadequate bowel preparation
- incapacity to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.
- Conditions
- Warm Water, CO2 Colonoscopy, Unsedated Colonoscopy
- Being tested
- CO2, Warm water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2Procedure or surgery
CO2 insufflation
Warm waterProcedure or surgery
warm water irrigation
| Study group | Role | What they receive |
|---|---|---|
| CO2 | Experimental | CO2 insufflation instead air insufflation in unsedated colonoscopy Receives: Procedure: CO2 |
| Warm Water irrigation | Experimental | warm water irrigation during the insertion phase of colonoscopy Receives: Procedure: Warm water |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients undergoing complete unsedated colonoscopy
Measured: 6 months
Secondary outcomes (1)
evaluation of pain and tolerability scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Warm WaterStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo Amato, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259583
- Sponsor's protocol ID
- CO2-01
- Status last verified
- Mar 2013
- First submitted
- 13 Dec 2010
- Last updated
- 13 Mar 2013
- Results posted
- No
Publications
Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.
PubMed 23478620
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy
- ClinicalTrials.gov ID
- NCT01259583
- Acronym / sponsor ID
- CO2-01
- Conditions
- Warm Water, CO2 Colonoscopy, Unsedated Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Dec 2010 (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.
Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 | Experimental | Procedure: CO2CO2 insufflation instead air insufflation in unsedated colonoscopy |
| Warm Water irrigation | Experimental | Procedure: Warm waterwarm water irrigation during the insertion phase of colonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult outpatients willing to undergo colonoscopy without routine initial sedation
Key exclusion criteria (3 listed)
- refuse to initiate colonoscopy without routine sedation
- inadequate bowel preparation
- incapacity to give informed consent
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 |
|---|---|---|
| CO2CO2 insufflation | Procedure or surgery | CO2 |
| Warm waterwarm water irrigation | Procedure or surgery | Warm Water irrigation |
Primary outcome
number of patients undergoing complete unsedated colonoscopy
Time frame: 6 months
1 secondary outcome
evaluation of pain and tolerability scores
Time frame: 6 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 13 Mar 2013.
- Derived from this study: PubMed 23478620Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.
Related trials for Warm Water
Not yet recruiting
The Effect of Abdomınal Massage and Warm Water Consumptıon on Postoperatıve Constıpatıon Development and Qualıty of Recovery in Patıents Undergoıng Hıp Fractures Surgery
Hip Fracture Surgeries
Not yet recruiting
Effect of Different Foot Baths on Postpartum Insomnia and Fatigue
Postpartum
Recruiting
Acupuncture and Moxibustion for Motor Symptoms in Early Parkinson's Disease
Parkinson's Disease (PD)
Recruiting
Cold Vs Warm Water Immersion for DOMS Recovery
Muscle Soreness
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 CO2 and Warm water in people with Warm Water and CO2 Colonoscopy, run by Valduce Hospital at 1 site in Italy.
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 3 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 13 Mar 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 Italy. 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?
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?
number of patients undergoing complete unsedated colonoscopy (time frame: 6 months). 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 NCT01259583, 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 13 Mar 2013.