Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening

NCT02041507 | Completed

• 2 other identifiers: PI.2013.2502Delibera 1047.2013
• Study Type: interventional
• Target: 1,224
• Locations: 3 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate.

  Proportion of subjects with at least one adenoma of any size.

  18 months.

Secondary Outcomes (9)

• Proximal colon Adenoma Detection Rate.

  18 months.

• Proximal colon <10 mm Adenoma Detection Rate.

  18 months.

• Mean adenomas resected per procedure.

  18 months.

• Cecal intubation rate.

  1 hour.

• Cecal intubation time.

  1 hour.

Other Outcomes (5)

• Loop reduction maneuvers.

  1 hour.

• Position changes. Position changes. Position changes. Position changes. Position changes.

  1 hour.

• Abdominal compression.

  1 hour.

Study Arms (3)

Air insufflation method.

ACTIVE COMPARATOR

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.

Other: Air insufflation method.

Water Immersion method.

EXPERIMENTAL

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.

Other: Water Immersion method.

Water Exchange method.

EXPERIMENTAL

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.

Other: Water Exchange method.

Interventions

Air insufflation method. OTHER

Air insufflation colonoscopy.

Air insufflation method.

Water Immersion method. OTHER

Water Immersion during insertion, air insufflation during withdrawal.

Water Immersion method.

Water Exchange method. OTHER

Water Exchange during insertion, air insufflation during withdrawal.

Water Exchange method.

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive screening patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Presidio Ospedaliero Santa Barbara: lead

Study Sites (4)

Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System

Los Angeles, California, 91343, United States

Location

Digestive Diseases Center, Vìtkovice Hospital

Ostrava, 703 84, Czechia

Location

Digestive Endoscopy Unit, Ospedale S. Barbara

Iglesias, CI, 09016, Italy

Location

Division of Gastroenterology, Ospedale Valduce

Como, CO, 22100, Italy

Location

Related Publications (7)

• 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.

  PMID: 22898423 BACKGROUND

• 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.

  PMID: 22835574 BACKGROUND

• 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.

  PMID: 24218307 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.

  PMID: 20883846 BACKGROUND

• Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.

  PMID: 23931857 BACKGROUND

• 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.

  PMID: 22987214 BACKGROUND

• 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.

  PMID: 28282689 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Pain

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergio Cadoni, MD

  S. Barbara Hospital, Iglesias (CI), Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsabile Servizio Endoscopia Digestiva

Study Record Dates

• First Submitted: January 18, 2014
• First Posted: January 22, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (1); CZ (1); IT (2)