Colorectal CancerNCT00785889
RCT of Air Insufflation Versus Water Infusion Colonoscopy
A study testing water infusion colonoscopy in people with Colorectal Cancer, run by East Bay Institute for Research and Education at 1 site in United States.
Trial summary
Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- water infusion colonoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2008
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individual 50 years or older
- eligible for colorectal cancer screening or surveillance
Who cannot join
- patients who do not understand or failed to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacramento VA Medical Center, VANCHCS
Mather, California, 95655
About this study
Official title: A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.
Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Read the detailed description
Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.
Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients.
Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.
Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.
Limitations: Single VA site, older male population
- Conditions
- Colorectal Cancer
- Being tested
- water infusion colonoscopy
- Keywords
- Colorectal cancer screening, optical colonoscopy, water method, sedation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water infusion colonoscopyProcedure or surgery
Also called optical colonoscopy, water infusion colonoscopy
water infusion in lieu of air insufflation for screening colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Increments of medications used for sedation
Measured: duration of procedure
Secondary outcomes (3)
pain scores during colonoscopy
Measured: duration of procedure
success with cecal intubation
Measured: during procedure
willingness to repeat colonoscopy
Measured: after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionOct 2008
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 Colorectal CancerStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Bay Institute for Research and Education
- Sponsor type
- University, hospital or other
- Investigators
- Joseph Leung, MD, Principal investigator, Sacramento VA Medical Center, GI Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785889
- Sponsor's protocol ID
- EBIRE-GI-001
- Status last verified
- Nov 2008
- First submitted
- 3 Nov 2008
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leung 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. Water-related techniques for performance of colonoscopy. Dig Dis Sci. 2008 Nov;53(11):2847-50. doi: 10.1007/s10620-008-0259-1. Epub 2008 May 7.
PubMed 18461455Leung FW, Aharonian HS, Guth PH, Chu SK, Nguyen BD, Simpson P. Involvement of trainees in routine unsedated colonoscopy: review of a pilot experience. Gastrointest Endosc. 2008 Apr;67(4):718-22. doi: 10.1016/j.gie.2007.11.040.
PubMed 18374030Leung 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 19555938
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.
- ClinicalTrials.gov ID
- NCT00785889
- Acronym / sponsor ID
- EBIRE-GI-001
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer screening, optical colonoscopy, water method, sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- East Bay Institute for Research and EducationUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Nov 2008 (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.
Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Detailed description
Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.
Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients.
Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.
Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.
Limitations: Single VA site, older male population
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy individual 50 years or older
- eligible for colorectal cancer screening or surveillance
Key exclusion criteria (1 listed)
- patients who do not understand or failed to sign 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 |
|---|---|---|
| water infusion colonoscopyAlso: optical colonoscopy, water infusion colonoscopywater infusion in lieu of air insufflation for screening colonoscopy | Procedure or surgery | – |
Primary outcome
Increments of medications used for sedation
Time frame: duration of procedure
3 secondary outcomes
pain scores during colonoscopy
Time frame: duration of procedure
success with cecal intubation
Time frame: during procedure
willingness to repeat colonoscopy
Time frame: after procedure
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 14 Nov 2008.
- 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 18461455Leung FW. Water-related techniques for performance of colonoscopy. Dig Dis Sci. 2008 Nov;53(11):2847-50. doi: 10.1007/s10620-008-0259-1. Epub 2008 May 7.
- Background: PubMed 18374030Leung FW, Aharonian HS, Guth PH, Chu SK, Nguyen BD, Simpson P. Involvement of trainees in routine unsedated colonoscopy: review of a pilot experience. Gastrointest Endosc. 2008 Apr;67(4):718-22. doi: 10.1016/j.gie.2007.11.040.
- Derived from this study: 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.
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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, GI Section
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 colonoscopy in people with Colorectal Cancer, run by East Bay Institute for Research and Education 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 2 inclusion and 1 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 14 Nov 2008. 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?
Increments of medications used for sedation (time frame: duration of 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 NCT00785889, 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 14 Nov 2008.