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

Adenoma Clinical Trial

Official title:

A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737514
• Other study ID #: DalinHsieh201402
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: February 2020

Study information

• Verified date: May 2020
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma

Intervention

Procedure:
• Air insufflation
Insufflation during colonoscopy including insertion phase
• water immersion
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
• water exchange
Water will infused and removed during insertion phase of colonoscopy

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi General Hospital	Chia-Yi
United States	Sepulveda Ambulatory Care Center, Veterans Affairs Greater	North Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Countries where clinical trial is conducted

United States,  Taiwan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenoma detection rate in the right colon		one week
Secondary	overall adenoma detection rate		one week
Secondary	post-procedure discomfort	pain or distention on a 0 to 10 VAS scale	1 day after colonoscopy
Secondary	30 days complication rate	incidence of bleeding, perforation and unexpected admission	30 days