Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy

• Sponsor: Dalin Tzu Chi General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02737514
• Collaborator: (none)
• Enrollment: 371
• Locations: 2
• Arms: 3
• Actual Duration (Months): 50
• Patients Per Site: 185.5
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Adenoma	Procedure: Air insufflation; Procedure: water immersion; Procedure: water exchange	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 371 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: air insufflation Air insufflation will be used throughout whole procedure of colonoscopy	Procedure: Air insufflation; Insufflation during colonoscopy including insertion phase
Active Comparator: water immersion Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy	Procedure: water immersion; Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
Active Comparator: water exchange Water will be infused and removed during insertion phase of colonoscopy	Procedure: water exchange; Water will infused and removed during insertion phase of colonoscopy

Outcome Measures

Primary Outcome Measures

1. adenoma detection rate in the right colon [one week]

Secondary Outcome Measures

1. overall adenoma detection rate [one week]

2. post-procedure discomfort [1 day after colonoscopy]

   pain or distention on a 0 to 10 VAS scale

3. 30 days complication rate [30 days]

   incidence of bleeding, perforation and unexpected admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sepulveda Ambulatory Care Center, Veterans Affairs Greater	North Hills	California	United States
2	Dalin Tzu Chi General Hospital	Chia-Yi		Taiwan	622

Sponsors and Collaborators

• Dalin Tzu Chi General Hospital

Investigators

• Principal Investigator: Yu-Hsi Hsieh, MD, Buddhist Dalin Tzu Chi General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Review.
• 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.
• 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.

• Responsible Party: Dalin Tzu Chi General Hospital
• ClinicalTrials.gov Identifier: NCT02737514
• Other Study ID Numbers: DalinHsieh201402
• First Posted: Apr 14, 2016
• Last Update Posted: May 29, 2020
• Last Verified: May 1, 2020

• Keywords provided by Dalin Tzu Chi General Hospital: adenoma detection rate; colonoscopy; water exchange
• Additional relevant MeSH terms: Adenoma

Study Results

No Results Posted as of May 29, 2020