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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-02-29

Brief Summary

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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

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Detailed Description

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

Conditions

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Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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air insufflation

Air insufflation will be used throughout whole procedure of colonoscopy

Group Type ACTIVE_COMPARATOR

Air insufflation

Intervention Type PROCEDURE

Insufflation during colonoscopy including insertion phase

water immersion

Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy

Group Type ACTIVE_COMPARATOR

water immersion

Intervention Type PROCEDURE

Water will infused during insertion phase and removed during withdrawal phase of colonoscopy

water exchange

Water will be infused and removed during insertion phase of colonoscopy

Group Type ACTIVE_COMPARATOR

water exchange

Intervention Type PROCEDURE

Water will infused and removed during insertion phase of colonoscopy

Interventions

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Air insufflation

Insufflation during colonoscopy including insertion phase

Intervention Type PROCEDURE

water immersion

Water will infused during insertion phase and removed during withdrawal phase of colonoscopy

Intervention Type PROCEDURE

water exchange

Water will infused and removed during insertion phase of colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No