Back to resultsThe Impact of Distraction on Adenoma Detection Rate
Primary Purpose
Adenoma
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Air insufflation
water immersion
Water exchange
Sponsored by
About this trial
This is an interventional prevention trial for Adenoma focused on measuring colonoscopy, water exchange, adenoma detection rate, distraction
Eligibility Criteria
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.
Sites / Locations
- Buddhist Dalin Tzu Chi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Air insufflation
water immersion
water exchange
Arm Description
Air insufflation will be used throughout whole procedure of colonoscopy
Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy
Water will be infused and removed during insertion phase of colonoscopy
Outcomes
Primary Outcome Measures
adenoma detection rate
Secondary Outcome Measures
Distraction score
Withdrawal technique as specified by Lee RH (citation 1)
adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment
Bowel preparation score
Boston bowel preparation score
Full Information
NCT ID
NCT02978664
First Posted
April 8, 2016
Last Updated
November 28, 2016
Sponsor
Dalin Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02978664
Brief Title
The Impact of Distraction on Adenoma Detection Rate
Official Title
The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalin Tzu Chi General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
colonoscopy, water exchange, adenoma detection rate, distraction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Air insufflation
Arm Type
Active Comparator
Arm Description
Air insufflation will be used throughout whole procedure of colonoscopy
Arm Title
water immersion
Arm Type
Active Comparator
Arm Description
Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy
Arm Title
water exchange
Arm Type
Active Comparator
Arm Description
Water will be infused and removed during insertion phase of colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Air insufflation
Intervention Description
Air insufflation during colonoscopy including insertion phase
Intervention Type
Procedure
Intervention Name(s)
water immersion
Intervention Description
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy.
Intervention Type
Procedure
Intervention Name(s)
Water exchange
Intervention Description
Water will infused and removed during insertion phase of colonoscopy
Primary Outcome Measure Information:
Title
adenoma detection rate
Time Frame
one week after colonoscopy
Secondary Outcome Measure Information:
Title
Distraction score
Time Frame
Immediate after video reviewing
Title
Withdrawal technique as specified by Lee RH (citation 1)
Description
adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment
Time Frame
immediate after video reviewing
Title
Bowel preparation score
Description
Boston bowel preparation score
Time Frame
immediate after video reviewing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsi Hsieh, MD
Organizational Affiliation
Dalin Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Dalin Tzu Chi General Hospital
City
Chia-Yi
ZIP/Postal Code
622
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21531410
Citation
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.
Results Reference
background
PubMed Identifier
21946120
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
31080608
Citation
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.
Results Reference
derived
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The Impact of Distraction on Adenoma Detection Rate
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