Water Immersion and Polyp Detection: A Randomized Controlled Trial

NCT ID: NCT03231917

Last Updated: 2019-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-08-31

Brief Summary

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We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one

Detailed Description

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Conditions

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Adenoma Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Water Infusion first

In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.

Group Type EXPERIMENTAL

Water Infusion first

Intervention Type PROCEDURE

In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.

CO2 Insufflation First

In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.

Group Type EXPERIMENTAL

CO2 Insufflation First

Intervention Type PROCEDURE

In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .

Interventions

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Water Infusion first

In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.

Intervention Type PROCEDURE

CO2 Insufflation First

In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University

Exclusion Criteria

* includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role collaborator

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Joseph Anderson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Anderson JC, Kahi CJ, Sullivan A, MacPhail M, Garcia J, Rex DK. Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach. Gastrointest Endosc. 2019 Mar;89(3):591-598. doi: 10.1016/j.gie.2018.09.046. Epub 2018 Oct 24.

Reference Type DERIVED
PMID: 30367879 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1000344-1

Identifier Type: -

Identifier Source: org_study_id

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