Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening
NCT ID: NCT02041507
Last Updated: 2016-04-13
Study Results
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Basic Information
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COMPLETED
NA
1224 participants
INTERVENTIONAL
2014-02-28
2016-04-30
Brief Summary
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Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was \>9 mm, P\<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy.
Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy.
In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for \<10 mm adenomas in the proximal colon.
In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy.
We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly \<10 mm adenomas, thus increasing proximal colon ADR and proximal colon ADR \<10 mm. Confirmation of secondary hypotheses will provide justification for further testing that WE may provide a strategy to improve prevention of colorectal cancer by increasing detection of adenomas in screening colonoscopy.
Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases of colonoscopy will be done by different investigators. The second investigator will be blinded to the method used to insert the instrument, thus eliminating possible bias about procedure related issues.
Several secondary outcomes will also be analysed.
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Detailed Description
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Control method: Air insufflation colonoscopy. Study methods: Water Immersion colonoscopy, Water Exchange colonoscopy.
Population: Consecutive 50 to 70 year-old screening patients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Primary outcome: overall Adenoma Detection Rate. Secondary outcomes: proximal colon ADR, Mean Adenomas resected per Procedure (MAP), cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), maximum pain during colonoscopy assessed during insertion and at discharge, the need for sedation/analgesia and its dosage. In addition loop reduction maneuvers, position changes, abdominal compression, the amount of infused and suctioned water during insertion and withdrawal, and patients willingness to repeat the examination will be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Air insufflation method.
Colonoscopy performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.
Air insufflation method.
Air insufflation colonoscopy.
Water Immersion method.
Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if \>3) if the lumen cannot be seen. Withdrawal phase done using air insufflation.
Water Immersion method.
Water Immersion during insertion, air insufflation during withdrawal.
Water Exchange method.
Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using air insufflation.
Water Exchange method.
Water Exchange during insertion, air insufflation during withdrawal.
Interventions
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Air insufflation method.
Air insufflation colonoscopy.
Water Immersion method.
Water Immersion during insertion, air insufflation during withdrawal.
Water Exchange method.
Water Exchange during insertion, air insufflation during withdrawal.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* surveillance colonoscopy
* previous colorectal surgery
* indication for a proctosigmoidoscopy or bidirectional endoscopy
* history of inflammatory bowel disease
* patient refusal or inability to provide informed consent
* inadequate consumption of bowel preparation
50 Years
70 Years
ALL
No
Sponsors
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Presidio Ospedaliero Santa Barbara
OTHER
Responsible Party
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Sergio Cadoni, M.D.
Responsabile Servizio Endoscopia Digestiva
Principal Investigators
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Sergio Cadoni, MD
Role: PRINCIPAL_INVESTIGATOR
S. Barbara Hospital, Iglesias (CI), Italy
Locations
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Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Digestive Diseases Center, Vìtkovice Hospital
Ostrava, , Czechia
Digestive Endoscopy Unit, Ospedale S. Barbara
Iglesias, CI, Italy
Division of Gastroenterology, Ospedale Valduce
Como, CO, Italy
Countries
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References
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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.
Gupta S, Balasubramanian BA, Fu T, Genta RM, Rockey DC, Lash R. Polyps with advanced neoplasia are smaller in the right than in the left colon: implications for colorectal cancer screening. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1395-1401.e2. doi: 10.1016/j.cgh.2012.07.004. Epub 2012 Jul 24.
Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11.
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.
Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.
Rabenstein T, Radaelli F, Zolk O. Warm water infusion colonoscopy: a review and meta-analysis. Endoscopy. 2012 Oct;44(10):940-51. doi: 10.1055/s-0032-1310157. Epub 2012 Sep 17.
Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10.
Other Identifiers
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Delibera 1047.2013
Identifier Type: OTHER
Identifier Source: secondary_id
PI.2013.2502
Identifier Type: -
Identifier Source: org_study_id
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