Comparison of Adenoma Detection Rate Among Water, Carbon Dioxide and Air Methods of Minimal Sedation Colonoscopy
NCT ID: NCT01782014
Last Updated: 2016-02-01
Study Results
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Basic Information
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TERMINATED
PHASE3
450 participants
INTERVENTIONAL
2013-02-28
2015-03-31
Brief Summary
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Hypothesis: the investigators hypothesize that in patients undergoing first time screening colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group randomized to the water method compared to those randomized to the air or CO2 insufflation methods
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Detailed Description
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ADR is an independent predictor of risk of post screening colonoscopy colon cancer. A simple method solely controlled by the colonoscopist that enhances proximal ADR holds the promise of rectifying some of the unresolved shortcomings of screening colonoscopy in failing to reduce the occurrence of post screening incident cancers in the proximal colon and the associated cancer mortality.
Hypotheses \& Specific Aims:
Primary Hypothesis:
In patients undergoing first time screening a higher ADR will be found in the proximal colon in those randomized to the water method compared to those randomized to the air method or CO2 method.
Secondary Hypotheses:
The examination method but not co-variables, procedure-related or patient-centered outcomes, is an independent predictor of proximal colon ADR.
Specific Aims:
This is a prospective, randomized, single-blinded controlled study to compare the study (water) and control 1 (air) method and control 2 (CO2 method) to aid insertion of the colonoscope. The proximal colon ADR, total ADR, co-variables, procedure-related and patient-centered outcomes and adverse event during and within 30 days of colonoscopy will be recorded and compared between the study and control methods.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Water Insufflation
Colonoscopy using water insufflation
colonoscopy
colonoscopy using different methods of insufflation
Carbon dioxide insufflation
Colonoscopy using carbon dioxide insufflation
colonoscopy
colonoscopy using different methods of insufflation
Air insufflation
Colonoscopy using air insufflation
colonoscopy
colonoscopy using different methods of insufflation
Interventions
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colonoscopy
colonoscopy using different methods of insufflation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* unable to give consent
* non-screening (surveillance or diagnostic) colonoscopy
* current participation in other colonoscopy studies
* a medical condition that could increase the risk associated with colonoscopy
* pregnancy
* those with a known family history of polyposis syndromes or a family history of colon cancer
18 Years
80 Years
ALL
Yes
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Kendrick Che, DO
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University Medical Center
Terrence Lewis, MD
Role: STUDY_CHAIR
Loma Linda University Medical Center
Michael Walter, MD
Role: STUDY_CHAIR
Loma Linda University Medical Center
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Countries
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References
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Leung FW, Aharonian HS, Leung JW, Guth PH, Jackson G. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):546-50. doi: 10.1016/j.gie.2008.08.014.
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.
Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.
Leung JW, Do LD, Siao-Salera RM, Ngo C, Parikh DA, Mann SK, Leung FW. Retrospective analysis showing the water method increased adenoma detection rate - a hypothesis generating observation. J Interv Gastroenterol. 2011 Jan;1(1):3-7. doi: 10.4161/jig.1.1.14585.
Leung FW, Leung JW, Siao-Salera RM, Mann SK. The water method significantly enhances proximal diminutive adenoma detection rate in unsedated patients. J Interv Gastroenterol. 2011 Jan;1(1):8-13. doi: 10.4161/jig.1.1.14587.
Leung FW, Leung JW, Siao-Salera RM, Mann SK, Jackson G. The water method significantly enhances detection of diminutive lesions (adenoma and hyperplastic polyp combined) in the proximal colon in screening colonoscopy - data derived from two RCT in US veterans. J Interv Gastroenterol. 2011 Apr;1(2):48-52. doi: 10.4161/jig.1.2.16826.
Stevenson GW, Wilson JA, Wilkinson J, Norman G, Goodacre RL. Pain following colonoscopy: elimination with carbon dioxide. Gastrointest Endosc. 1992 Sep-Oct;38(5):564-7. doi: 10.1016/s0016-5107(92)70517-3.
Wong JC, Yau KK, Cheung HY, Wong DC, Chung CC, Li MK. Towards painless colonoscopy: a randomized controlled trial on carbon dioxide-insufflating colonoscopy. ANZ J Surg. 2008 Oct;78(10):871-4. doi: 10.1111/j.1445-2197.2008.04683.x.
Leung FW, Leung JW, Mann SK, Friedland S, Ramirez FC. The water method significantly enhances patient-centered outcomes in sedated and unsedated colonoscopy. Endoscopy. 2011 Sep;43(9):816-21. doi: 10.1055/s-0030-1256407. Epub 2011 May 24.
Other Identifiers
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LLUMCGI2013
Identifier Type: OTHER
Identifier Source: secondary_id
5130003
Identifier Type: -
Identifier Source: org_study_id
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