Clinical trial NCT01894191: Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange
Official title: A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Keywords: adenoma detection rate
colonoscopy
water exchange
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
Collaborators: name: Sepulveda Ambulatory Care Center, VAGLAHS
First posted: 2013-07-10
Enrollment: 651
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: All of the procedures will be recorded and stored as digital files.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing colonoscopy performed by the participating endoscopists

Exclusion Criteria:

* obstructive lesions of the colon known before colonoscopy
* massive ascites
* past history of partial colectomy
* refusal to provide written informed consent

Primary outcomes:
measure: adenoma detection rate
timeFrame: one week
Secondary outcomes:
measure: adenoma detection rate in proximal colon
timeFrame: one week
Other outcomes:
measure: post-procedure discomfort and 30 days complication rate
timeFrame: 30 days
Locations:
city: North Hills
country: United States
facility: Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
state: California
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu Chi General Hospital
Study officials:
affiliation: Buddhist Dalin Tzu Chi Hospital
name: Yu-Hsi Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Stock 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.
citation: Leung 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.
citation: Radaelli 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.
citation: Hsieh 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.
citation: Hsieh 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.