ColonoscopyNCT00671177
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
A study testing water immersion colonoscopy and standard air colonoscopy in people with Colonoscopy and Digestive System, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Colonoscopy, Digestive System, Endoscopy
- What is being tested?
- water immersion colonoscopy and standard air colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2008
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presentation for colonoscopy
- male
- age 18 or older
Who cannot join
- women
- known inflammatory bowel disease
- presentation for emergency colonoscopy
- history of partial colectomy
- chronic narcotic or benzodiazepine use
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.
- Conditions
- Colonoscopy, Digestive System, Endoscopy, Gastrointestinal Disease
- Being tested
- water immersion colonoscopy, standard air colonoscopy
- Keywords
- colonoscopy, diagnostic techniques, digestive system, endoscopy, gastrointestinal
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water immersion colonoscopyProcedure or surgery
instillation of 300cc of water in the rectum
standard air colonoscopyProcedure or surgery
air instillation in colon for visualization
| Study group | Role | What they receive |
|---|---|---|
| Water Immersion Colonoscopy | Experimental | Water Immersion Colonoscopy Receives: Procedure: water immersion colonoscopy |
| Standard Air Colonoscopy | Active comparator | Standard Air Colonoscopy Receives: Procedure: standard air colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy Success With Minimal Sedation
Measured: At the time of the procedure
Secondary outcomes (2)
Time to Cecum
Measured: At the time of the procedure
Patient Satisfaction
Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionJun 2008
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
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Roy Soetikno, VA Palo Alto Health Care System
- Investigators
- Roy Soetikno, MD, MS, Principal investigator, VA Palo Alto/Stanford University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671177
- Sponsor's protocol ID
- Protocol10642
- Status last verified
- Mar 2017
- First submitted
- 1 May 2008
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.
PubMed 20593332
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
- ClinicalTrials.gov ID
- NCT00671177
- Acronym / sponsor ID
- Protocol10642
- Conditions
- Colonoscopy, Digestive System, Endoscopy, Gastrointestinal Disease
- Keywords
- colonoscopy, diagnostic techniques, digestive system, endoscopy, gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Immersion Colonoscopy | Experimental | Procedure: water immersion colonoscopyWater Immersion Colonoscopy |
| Standard Air Colonoscopy | Active comparator | Procedure: standard air colonoscopyStandard Air Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presentation for colonoscopy
- male
- age 18 or older
Key exclusion criteria (5 listed)
- women
- known inflammatory bowel disease
- presentation for emergency colonoscopy
- history of partial colectomy
- chronic narcotic or benzodiazepine use
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 colonoscopyinstillation of 300cc of water in the rectum | Procedure or surgery | Water Immersion Colonoscopy |
| standard air colonoscopyair instillation in colon for visualization | Procedure or surgery | Standard Air Colonoscopy |
Primary outcome
Colonoscopy Success With Minimal Sedation
Time frame: At the time of the procedure
2 secondary outcomes
Time to Cecum
Time frame: At the time of the procedure
Patient Satisfaction
Time frame: At the time of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20593332Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.
- Individual participant dataSharing planned: No
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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.
Roy Soetikno, MD, MS principal investigator
VA Palo Alto/Stanford University Medical Center
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 colonoscopy and standard air colonoscopy in people with Colonoscopy and Digestive System, run by VA Palo Alto Health Care System 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 3 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 1 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 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?
Yes. Results are posted in the registry (first posted 1 May 2017). 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?
Colonoscopy Success With Minimal Sedation (time frame: At the time of the procedure). 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 NCT00671177, 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 1 May 2017.