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| Name | Class |
|---|---|
| Sepulveda Ambulatory Care Center, VAGLAHS | UNKNOWN |
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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.
All of the procedures will be recorded and stored as digital files.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| air insufflation | Active Comparator | Air insufflation will be used throughout whole procedure of colonoscopy |
|
| water immersion | Active Comparator | Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy. |
|
| water exchange | Active Comparator | Water will be infused and removed during insertion phase of colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air insufflation | Procedure | Insufflation during colonoscopy including insertion phase |
| |
| Measure | Description | Time Frame |
|---|---|---|
| adenoma detection rate | one week |
| Measure | Description | Time Frame |
|---|---|---|
| adenoma detection rate in proximal colon | the proportion of patients with the presence of adenoma in the proximal colon | one week |
| Measure | Description | Time Frame |
|---|---|---|
| post-procedure discomfort and 30 days complication rate | telephone follow up for post-procedure discomfort and 30 days complication rate | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Hsi Hsieh, MD | Buddhist Dalin Tzu Chi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System | North Hills | California | 91343 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15300577 | Background | 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. | |
| 22341107 | Background | 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. |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| water immersion |
| Procedure |
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy |
|
| Water exchange | Procedure | Water will infused and removed during insertion phase of colonoscopy |
|
| Dalin Tzu Chi General Hospital |
| Chiayi City |
| Taiwan |
| 622 |
| Taiwan |
| 22898423 | Background | 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. |
| 20883846 | Background | 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. |
| 21633535 | Background | 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. |
| 27988288 | Derived | 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. |