The Impact of Distraction on Adenoma Detection Rate

November 28, 2016 updated by: Dalin Tzu Chi General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chia-Yi, Taiwan, 622
        • Buddhist Dalin Tzu Chi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: water exchange
Water will be infused and removed during insertion phase of colonoscopy
Procedure: Water exchange
Water will infused and removed during insertion phase of colonoscopy
Active Comparator: Air insufflation
Air insufflation will be used throughout whole procedure of colonoscopy
Procedure: Air insufflation
Air insufflation during colonoscopy including insertion phase
Active Comparator: water immersion
Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy
Procedure: water immersion
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adenoma detection rate
Time Frame: one week after colonoscopy
one week after colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distraction score
Time Frame: Immediate after video reviewing
Immediate after video reviewing
Withdrawal technique as specified by Lee RH (citation 1)
Time Frame: immediate after video reviewing
adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment
immediate after video reviewing
Bowel preparation score
Time Frame: immediate after video reviewing
Boston bowel preparation score
immediate after video reviewing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Investigators

  • Principal Investigator: Yu-Hsi Hsieh, MD, Dalin Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

December 1, 2016

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DalinHsieh201401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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