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

Not Applicable

Completed

• Conditions: Adenoma
• Interventions: Procedure: Air insufflation; Procedure: water immersion; Procedure: water exchange

• Registration Number: NCT02737514
• Lead Sponsor: Dalin Tzu Chi General Hospital

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-08-25
• Study Start: 2015-12
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-14
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
air insufflation	Air insufflation	Air insufflation will be used throughout whole procedure of colonoscopy
water immersion	water immersion	Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy
water exchange	water exchange	Water will be infused and removed during insertion phase of colonoscopy

Primary Outcome Measures

Name	Time	Method
adenoma detection rate in the right colon	one week

Secondary Outcome Measures

Name	Time	Method
overall adenoma detection rate	one week
post-procedure discomfort	1 day after colonoscopy	pain or distention on a 0 to 10 VAS scale
30 days complication rate	30 days	incidence of bleeding, perforation and unexpected admission

Trial Locations

Locations (2)

Dalin Tzu Chi General Hospital; 🇨🇳 Chia-Yi, Taiwan

Sepulveda Ambulatory Care Center, Veterans Affairs Greater; 🇺🇸 North Hills, California, United States