Back to resultsEffect of Video Monitor Size on Adenoma Detection Rate
Primary Purpose
Colon Adenoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monitor size
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Adenoma
Eligibility Criteria
Inclusion Criteria:
- Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit
- Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit
Exclusion Criteria:
- Refusal to participate
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard monitor (24")
Large monitor (32")
Arm Description
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
Outcomes
Primary Outcome Measures
Adenoma Detection Rate (All Indications)
Number of patients with adenoma detected
Adenoma Detection Rate (Screening Exams Only)
Number of patients with adenoma detected
Secondary Outcome Measures
Polyp Detection Rate (All Indications)
Number of patients with polyps detected
Polyp Detection Rate (Screening Exams Only)
Number of patients with polyps detected
Full Information
NCT ID
NCT01952418
First Posted
September 19, 2013
Last Updated
April 21, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01952418
Brief Title
Effect of Video Monitor Size on Adenoma Detection Rate
Official Title
Effect of Video Monitor Size on Adenoma Detection Rate
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.
Detailed Description
Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26") used at this facility while the other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in each room will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
15 endoscopists and 1805 patients on which procedures were performed were randomly assigned to each room.
Allocation
Randomized
Enrollment
1805 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard monitor (24")
Arm Type
No Intervention
Arm Description
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
Arm Title
Large monitor (32")
Arm Type
Active Comparator
Arm Description
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
Intervention Type
Device
Intervention Name(s)
Monitor size
Intervention Description
Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32") video monitor or the standard (24") video monitor.
Primary Outcome Measure Information:
Title
Adenoma Detection Rate (All Indications)
Description
Number of patients with adenoma detected
Time Frame
within 2 weeks (range of 1 day-14 days) of the endoscopy
Title
Adenoma Detection Rate (Screening Exams Only)
Description
Number of patients with adenoma detected
Time Frame
within 2 weeks (range of 1 day-14 days) of the endoscopy
Secondary Outcome Measure Information:
Title
Polyp Detection Rate (All Indications)
Description
Number of patients with polyps detected
Time Frame
recorded during endoscopy (immediate)
Title
Polyp Detection Rate (Screening Exams Only)
Description
Number of patients with polyps detected
Time Frame
recorded during endoscopy (immediate)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit
Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit
Exclusion Criteria:
Refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman S Nishioka, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30986402
Citation
Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12.
Results Reference
derived
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Effect of Video Monitor Size on Adenoma Detection Rate
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