ColonoscopyNCT01322724
Comparing Warm Versus Cool Temperature Water During Colonoscopy
A study testing Warm vs Cool water in people with Colonoscopy, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Warm vs Cool water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2012
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening
Who cannot join
- Patients undergoing colonoscopy for any other indication besides colon cancer screening
- Patients with prior colonic resections
- Patients with chronic narcotic or benzodiazepine use
- Poor bowel preparation (i.e. Boston bowel preparation score < 8)
- Patients with obstructing colonic lesions detected on colonoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.
- Conditions
- Colonoscopy
- Being tested
- Warm vs Cool water
- Keywords
- colonoscopy, colon cancer screening, patient discomfort scores, sedation medication requirements, water insertion method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm vs Cool waterProcedure or surgery
Body vs Room temperature water used during insertion of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Warm water | Active comparator | Body temperature (95-100 degrees F) water Receives: Procedure: Warm vs Cool water |
| Cool water | Experimental | Room temperature (68-73 degrees F) water Receives: Procedure: Warm vs Cool water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of sedation medication used (fentanyl and midazolam)
Measured: Duration of the colonoscopy; Up to 3 hours
Secondary outcomes (1)
Patient pain/discomfort score
Measured: During the day of the procedure; Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionApr 2012
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 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Brian Fennerty, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322724
- Sponsor's protocol ID
- 00007299
- Status last verified
- May 2012
- First submitted
- 24 Mar 2011
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee BY, Katon R, Herzig D, Fennerty MB. Warm water infusion during sedated colonoscopy does not decrease amount of sedation medication used. Gastrointest Endosc. 2012 Dec;76(6):1182-7. doi: 10.1016/j.gie.2012.08.002. Epub 2012 Sep 26.
PubMed 23021168
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Warm Versus Cool Temperature Water During Colonoscopy
- ClinicalTrials.gov ID
- NCT01322724
- Acronym / sponsor ID
- 00007299
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, colon cancer screening, patient discomfort scores, sedation medication requirements, water insertion method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 25 Mar 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.
The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm water | Active comparator | Procedure: Warm vs Cool waterBody temperature (95-100 degrees F) water |
| Cool water | Experimental | Procedure: Warm vs Cool waterRoom temperature (68-73 degrees F) water |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening
Key exclusion criteria (5 listed)
- Patients undergoing colonoscopy for any other indication besides colon cancer screening
- Patients with prior colonic resections
- Patients with chronic narcotic or benzodiazepine use
- Poor bowel preparation (i.e. Boston bowel preparation score < 8)
- Patients with obstructing colonic lesions detected on colonoscopy
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 |
|---|---|---|
| Warm vs Cool waterBody vs Room temperature water used during insertion of colonoscopy | Procedure or surgery | Cool water, Warm water |
Primary outcome
Dose of sedation medication used (fentanyl and midazolam)
Time frame: Duration of the colonoscopy; Up to 3 hours
1 secondary outcome
Patient pain/discomfort score
Time frame: During the day of the procedure; Up to 1 day
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 25 May 2012.
- Derived from this study: PubMed 23021168Lee BY, Katon R, Herzig D, Fennerty MB. Warm water infusion during sedated colonoscopy does not decrease amount of sedation medication used. Gastrointest Endosc. 2012 Dec;76(6):1182-7. doi: 10.1016/j.gie.2012.08.002. Epub 2012 Sep 26.
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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.
M. Brian Fennerty, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm vs Cool water in people with Colonoscopy, run by OHSU Knight Cancer Institute at 1 site in United States.
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 25 May 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 United States. 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?
Dose of sedation medication used (fentanyl and midazolam) (time frame: Duration of the colonoscopy; Up to 3 hours). 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 NCT01322724, 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 25 May 2012.