The Impact of Distraction on Adenoma Detection Rate

NCT ID: NCT02978664

Last Updated: 2016-12-01

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

Brief Summary

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The investigators will review video-recordings of three randomized, controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi Hospital.

Detailed Description

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The investigators will review video-recordings of three randomized controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be obtained from the local Institutional Review Board (IRB) to review, analyze and report de-identified findings.

Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies. Recordings will be selected for review if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection will be excluded from analysis. The included video recordings will be edited to remove the insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer uninvolved in the performance of the colonoscopies will be in charge of evaluating the selected videos, using the criteria described by Yung et al

Conditions

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Adenoma

Keywords

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colonoscopy water exchange adenoma detection rate distraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators 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

Air 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

Air 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

* if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers.

Exclusion Criteria

* Patients with incomplete recordings and a history of bowel resection will be excluded from analysis.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Hsi Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Dalin Tzu Chi General Hospital

Locations

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Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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Lee RH, Tang RS, Muthusamy VR, Ho SB, Shah NK, Wetzel L, Bain AS, Mackintosh EE, Paek AM, Crissien AM, Saraf LJ, Kalmaz DM, Savides TJ. Quality of colonoscopy withdrawal technique and variability in adenoma detection rates (with videos). Gastrointest Endosc. 2011 Jul;74(1):128-34. doi: 10.1016/j.gie.2011.03.003. Epub 2011 Apr 30.

Reference Type BACKGROUND
PMID: 21531410 (View on PubMed)

Leung FW. Water exchange may be superior to water immersion for colonoscopy. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1012-4. doi: 10.1016/j.cgh.2011.09.007. Epub 2011 Sep 22. No abstract available.

Reference Type BACKGROUND
PMID: 21946120 (View on PubMed)

Yung VY, Yen AW, Leung JW, Mann SK, Wilson MD, Leung FW. Validation of a novel method for analyzing video recordings of the withdrawal phase of air insufflation and water exchange colonoscopy - documentation of distractions from focused mucosal inspection. J Interv Gastroenterol. 2014 Jan;4(1):8-12.

Reference Type BACKGROUND

Hsieh YH, Koo M, Tseng CW, Yang HW, Leung FW. Reduction of multitasking distractions underlies the higher adenoma detection rate of water exchange compared to air insufflation - blinded analysis of withdrawal phase videos. United European Gastroenterol J. 2019 Mar;7(2):230-238. doi: 10.1177/2050640618817105. Epub 2018 Dec 5.

Reference Type DERIVED
PMID: 31080608 (View on PubMed)

Other Identifiers

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DalinHsieh201401

Identifier Type: -

Identifier Source: org_study_id