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Clinical Trials/NCT02978664
NCT02978664CompletedNot Applicable

The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange

Dalin Tzu Chi General Hospital1 site in 1 country500 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
adenoma detection rate

Study Overview

Brief Summary

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

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

water immersion

Active Comparator

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

Intervention: water immersion (Procedure)

water exchange

Active Comparator

Water will be infused and removed during insertion phase of colonoscopy

Intervention: Water exchange (Procedure)

Air insufflation

Active Comparator

Air insufflation will be used throughout whole procedure of colonoscopy

Intervention: Air insufflation (Procedure)

Outcomes

Primary Outcomes

adenoma detection rate

Time Frame: one week after colonoscopy

Secondary Outcomes

  • Distraction score(Immediate after video reviewing)
  • Withdrawal technique as specified by Lee RH (citation 1)(immediate after video reviewing)
  • Bowel preparation score(immediate after video reviewing)

Investigators

Sponsor
Dalin Tzu Chi General Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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