Gastrointestinal DiseasesEarly Phase 1WWNCT01463319
Warm Water and Unsedated Colonoscopy
A Early Phase 1 study testing air insufflation and warm water irrigation in people with Gastrointestinal Diseases and Digestive System Diseases, run by Presidio Ospedaliero Santa Barbara at 2 sites in Italy.
Trial summary
Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Digestive System Diseases
- What is being tested?
- air insufflation and warm water irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2011to Sep 2012
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 Years to 85 Years
- adult patients 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
2 sites in 1 country.
Italy2 sites
Servizio Endoscopia Digestiva
Iglesias, Carbonia-Iglesias, 09016
U.O.S.D. Diagnostica e Terapia Endoscopica
San Gavino Monreale, Medio Campidano (VS), 09037
About this study
Official title: Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy
Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.
- Being tested
- air insufflation, warm water irrigation
- Keywords
- colonoscopy, warm water method, hydrocolonoscopy, unsedated colonoscopy
- Medical subject headings
- Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air insufflationOther
air insufflation during insertion phase colonoscopy
warm water irrigationOther
warm water irrigation during insertion phase colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| warm water irrigation | Experimental | warm water irrigation during insertion phase of colonoscopy Receives: Other: warm water irrigation |
| air insufflation | Experimental | air insufflation during insertion phase of colonoscopy Receives: Other: air insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients undergoing complete unsedated or slightly sedated colonoscopy
number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) ≤2, or patients with no more than that score AND ≤2 mg Midazolam E.V.
Measured: 9 months
Secondary outcomes (4)
evaluation of pain and tolerability scores
Numeric rating scale, Verbal Descriptor Scale and Faces Pain Scale (0= no pain, 10 worst possible pain.) Hicks CL et al. Pain 2001;93:173-183. Bieri D. et al. Pain. 1990;41(2):138-50.
Measured: 1 hour
percentage of caecum intubation
Measured: 1 hour
time to reach caecum
Measured: 1 hour
Adenoma detection rate
Proportion of patients with at least one adenoma of any size
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Ospedaliero Santa Barbara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara
- Investigators
- Sergio Cadoni, M.D., Principal investigator, A.S.L. 07 Sardegna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463319
- Sponsor's protocol ID
- ASL07_WW-2011
- Acronym
- WW
- Status last verified
- Feb 2013
- First submitted
- 25 Oct 2011
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy
- ClinicalTrials.gov ID
- NCT01463319
- Acronym / sponsor ID
- WW / ASL07_WW-2011
- Keywords
- colonoscopy, warm water method, hydrocolonoscopy, unsedated colonoscopy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Presidio Ospedaliero Santa BarbaraUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Nov 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.
Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warm water irrigation | Experimental | Other: warm water irrigationwarm water irrigation during insertion phase of colonoscopy |
| air insufflation | Experimental | Other: air insufflationair insufflation during insertion phase of colonoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 Years to 85 Years
- adult patients 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 |
|---|---|---|
| air insufflationair insufflation during insertion phase colonoscopy | Other | air insufflation |
| warm water irrigationwarm water irrigation during insertion phase colonoscopy | Other | warm water irrigation |
Primary outcome
number of patients undergoing complete unsedated or slightly sedated colonoscopy
Time frame: 9 months
number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) ≤2, or patients with no more than that score AND ≤2 mg Midazolam E.V.
4 secondary outcomes
evaluation of pain and tolerability scores
Time frame: 1 hour
percentage of caecum intubation
Time frame: 1 hour
time to reach caecum
Time frame: 1 hour
Adenoma detection rate
Time frame: 9 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 8 Feb 2013.
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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.
Sergio Cadoni, M.D. principal investigator
A.S.L. 07 Sardegna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing air insufflation and warm water irrigation in people with Gastrointestinal Diseases and Digestive System Diseases, run by Presidio Ospedaliero Santa Barbara at 2 sites 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 2 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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
number of patients undergoing complete unsedated or slightly sedated colonoscopy (time frame: 9 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 8 Feb 2013; AzTrials last refreshed its copy on 31 Oct 2026.