Colon PolypNCT01383252
Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
A study testing Water infusion in lieu of air insufflation and Air method in people with Colon Polyp, run by VA Northern California Health Care System at 1 site in United States.
Trial summary
In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that: 1. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colon Polyp
- What is being tested?
- Water infusion in lieu of air insufflation and Air method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2013
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>50 years old)
- Male and female patients
- Scheduled and consented for screening or surveillance colonoscopy without medications
- Accept randomization to the study or the conventional method
- Agree to complete study questionnaires
- The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.
Who cannot join
- Patients who decline to participate
- Unable to give informed consent or complete the questionnaires due to language or other difficulties
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacramento VA Medical Center
Mather, California, 95655
About this study
Official title: Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:
- Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
- Study method improves bowel preparation and increases polyp pickup rate
Read the detailed description
Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.
The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.
In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.
- Conditions
- Colon Polyp
- Being tested
- Water infusion in lieu of air insufflation, Air method
- Keywords
- water method, air method, unsedated colonoscopy, adenoma detection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water infusion in lieu of air insufflationProcedure or surgery
Also called Water method, Screening colonoscopy
Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.
Air methodProcedure or surgery
Also called Screening colonoscopy
Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.
| Study group | Role | What they receive |
|---|---|---|
| Water method | Experimental | Water infusion in lieu of air insufflation for screening and surveillance colonoscopy Receives: Procedure: Water infusion in lieu of air insufflation |
| Air method | Active comparator | Air insufflation for screening and surveillance colonoscopy Receives: Procedure: Air method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of colonoscopy
successful cecal intubation
Measured: 24 months
Secondary outcomes (1)
Polyp detection
Adenoma detection rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon PolypStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Northern California Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph Leung, MD, Principal investigator, Sacramento VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383252
- Sponsor's protocol ID
- VANCHCS-GI-005
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2011
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
PubMed 19555938Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. doi: 10.1111/j.1365-2036.2007.03404.x.
PubMed 17661766Leung FW, Mann SK, Salera R, Toomsen L, Cabrera H, Prather D, Gutierrez R, Leung JW. Options for screening colonoscopy without sedation: sequel to a pilot study in U.S. veterans. Gastrointest Endosc. 2008 Apr;67(4):712-7. doi: 10.1016/j.gie.2007.10.028. Epub 2008 Feb 14.
PubMed 18279868Leung JW, Salera R, Toomsen L, Mann S, Leung FW. Pilot feasibility study of the method of water infusion without air insufflation in sedated colonoscopy. Dig Dis Sci. 2009 Sep;54(9):1997-2001. doi: 10.1007/s10620-008-0576-4. Epub 2008 Dec 5.
PubMed 19058003
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
- ClinicalTrials.gov ID
- NCT01383252
- Acronym / sponsor ID
- VANCHCS-GI-005
- Conditions
- Colon Polyp
- Keywords
- water method, air method, unsedated colonoscopy, adenoma detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Northern California Health Care SystemUS federal agency
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jun 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.
In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:
- Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
- Study method improves bowel preparation and increases polyp pickup rate
Detailed description
Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.
The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.
In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water method | Experimental | Procedure: Water infusion in lieu of air insufflationWater infusion in lieu of air insufflation for screening and surveillance colonoscopy |
| Air method | Active comparator | Procedure: Air methodAir insufflation for screening and surveillance colonoscopy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (>50 years old)
- Male and female patients
- Scheduled and consented for screening or surveillance colonoscopy without medications
- Accept randomization to the study or the conventional method
- Agree to complete study questionnaires
Key exclusion criteria (2 listed)
- Patients who decline to participate
- Unable to give informed consent or complete the questionnaires due to language or other difficulties
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 infusion in lieu of air insufflationAlso: Water method, Screening colonoscopyAir pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion. | Procedure or surgery | Water method |
| Air methodAlso: Screening colonoscopyConventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing. | Procedure or surgery | Air method |
Primary outcome
Success of colonoscopy
Time frame: 24 months
successful cecal intubation
1 secondary outcome
Polyp detection
Time frame: 24 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 17 Jun 2013.
- Background: PubMed 19555938Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
- Background: PubMed 17661766Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. doi: 10.1111/j.1365-2036.2007.03404.x.
- Background: PubMed 18279868Leung FW, Mann SK, Salera R, Toomsen L, Cabrera H, Prather D, Gutierrez R, Leung JW. Options for screening colonoscopy without sedation: sequel to a pilot study in U.S. veterans. Gastrointest Endosc. 2008 Apr;67(4):712-7. doi: 10.1016/j.gie.2007.10.028. Epub 2008 Feb 14.
- Background: PubMed 19058003Leung JW, Salera R, Toomsen L, Mann S, Leung FW. Pilot feasibility study of the method of water infusion without air insufflation in sedated colonoscopy. Dig Dis Sci. 2009 Sep;54(9):1997-2001. doi: 10.1007/s10620-008-0576-4. Epub 2008 Dec 5.
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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.
Joseph Leung, MD principal investigator
Sacramento VA 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 infusion in lieu of air insufflation and Air method in people with Colon Polyp, run by VA Northern California 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 6 inclusion and 2 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 17 Jun 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 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?
Success of colonoscopy (time frame: 24 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 NCT01383252, which also lists 4 linked publications.
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 17 Jun 2013.