Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange
A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy
1 other identifier
interventional
651
2 countries
2
Brief Summary
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 3, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 28, 2016
June 1, 2016
2.6 years
July 3, 2013
June 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adenoma detection rate
one week
Secondary Outcomes (1)
adenoma detection rate in proximal colon
one week
Other Outcomes (1)
post-procedure discomfort and 30 days complication rate
30 days
Study Arms (3)
air insufflation
ACTIVE COMPARATORAir insufflation will be used throughout whole procedure of colonoscopy
water immersion
ACTIVE COMPARATORWater will be infused during the insertion phase and removed during withdrawal phase of colonoscopy.
water exchange
ACTIVE COMPARATORWater will be infused and removed during insertion phase of colonoscopy
Interventions
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
Water will infused and removed during insertion phase of colonoscopy
Eligibility Criteria
You may qualify if:
- Patients undergoing colonoscopy performed by the participating endoscopists
You may not qualify if:
- obstructive lesions of the colon known before colonoscopy
- massive ascites
- past history of partial colectomy
- refusal to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
North Hills, California, 91343, United States
Dalin Tzu Chi General Hospital
Chiayi City, Taiwan, 622, Taiwan
Related Publications (6)
Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
PMID: 15300577BACKGROUNDStock C, Pulte D, Haug U, Brenner H. Subsite-specific colorectal cancer risk in the colorectal endoscopy era. Gastrointest Endosc. 2012 Mar;75(3):621-30. doi: 10.1016/j.gie.2011.10.025.
PMID: 22341107BACKGROUNDLeung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
PMID: 22898423BACKGROUNDRadaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
PMID: 20883846BACKGROUNDHsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
PMID: 21633535BACKGROUNDHsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.
PMID: 27988288DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Hsi Hsieh, MD
Buddhist Dalin Tzu Chi Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 3, 2013
First Posted
July 10, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 28, 2016
Record last verified: 2016-06