Clinical trial NCT02041507: Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening
Official title: A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange for Adenoma Detection Rate in Screening Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Adenomas
Colorectal Polyps
Pain
Keywords: Water-aided colonoscopy
Water Immersion
Water Exchange
On-demand sedation
Unsedated colonoscopy
Adenoma detection rate
Mean adenomas per procedure
Lead sponsor: Presidio Ospedaliero Santa Barbara
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 1224
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer.

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.

Detailed description: Design: Prospective double-blinded multicenter randomized controlled trial. Methods: Colonoscopy with Air Insufflation, Water Immersion, Water Exchange to aid insertion of colonoscope; split dose bowel preparation. Sedation available at the start of the procedure or on-demand.

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.

Eligibility criteria: Inclusion Criteria:

* consecutive screening patients

Exclusion Criteria:

* previous colonoscopy within 5 years
* 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

Primary outcomes:
measure: Adenoma Detection Rate.
timeFrame: 18 months.
Secondary outcomes:
measure: Proximal colon Adenoma Detection Rate.
timeFrame: 18 months.
measure: Proximal colon <10 mm Adenoma Detection Rate.
timeFrame: 18 months.
measure: Mean adenomas resected per procedure.
timeFrame: 18 months.
measure: Cecal intubation rate.
timeFrame: 1 hour.
measure: Cecal intubation time.
timeFrame: 1 hour.
measure: Total procedure time.
timeFrame: 1 hour.
measure: Maximum pain score recorded during insertion phase of colonoscopy.
timeFrame: 1 hour.
measure: Pain score at discharge.
timeFrame: 1 hour.
measure: Need for sedation/analgesia and its dosage
timeFrame: 1 hour.
Other outcomes:
measure: Loop reduction maneuvers.
timeFrame: 1 hour.
measure: Position changes. Position changes. Position changes. Position changes. Position changes.
timeFrame: 1 hour.
measure: Abdominal compression.
timeFrame: 1 hour.
measure: Amount of water used during the procedure.
timeFrame: 1 hour.
measure: Patients willingness to repeat the examination.
timeFrame: 1 hour.
Locations:
city: Los Angeles
country: United States
facility: Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
state: California
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center, Vìtkovice Hospital
city: Iglesias
country: Italy
facility: Digestive Endoscopy Unit, Ospedale S. Barbara
state: CI
city: Como
country: Italy
facility: Division of Gastroenterology, Ospedale Valduce
state: CO
Study officials:
affiliation: S. Barbara Hospital, Iglesias (CI), Italy
name: Sergio Cadoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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: Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.
citation: 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.
citation: 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.