Back to resultsCT and Radiologist RCT
Primary Purpose
Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Exam Findings
Inaccurate Clinical Exam Findings
No clinical exam findings
Sponsored by
About this trial
This is an interventional diagnostic trial for Hernia
Eligibility Criteria
Participants are radiologists at LBJ Hospital.
Sites / Locations
- UT Health at Lyndon B. Johnson General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Accurate Clinical Exam Findings
Inaccurate Clinical Exam Findings
No Clinical Exam Findings
Arm Description
Radiologists will be provided with accurate clinical exam data.
Radiologists will be provided with purposefully incorrect clinical exam data
Radiologists will be not be provided with any clinical exam data
Outcomes
Primary Outcome Measures
Hernia detected on CT
proportion of hernias detected on CT
Secondary Outcome Measures
Full Information
NCT ID
NCT03121131
First Posted
April 14, 2017
Last Updated
April 10, 2020
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03121131
Brief Title
CT and Radiologist RCT
Official Title
How Important is a Clinical Data for a Radiologist? A Double-Blinded Randomized Controlled Trial of Radiologic Interpretation of Ventral Hernias Following Selectively-Provided Clinical Information
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors.
The researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of CT scans for the presence/absence of a ventral hernia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accurate Clinical Exam Findings
Arm Type
Other
Arm Description
Radiologists will be provided with accurate clinical exam data.
Arm Title
Inaccurate Clinical Exam Findings
Arm Type
Other
Arm Description
Radiologists will be provided with purposefully incorrect clinical exam data
Arm Title
No Clinical Exam Findings
Arm Type
Other
Arm Description
Radiologists will be not be provided with any clinical exam data
Intervention Type
Other
Intervention Name(s)
Clinical Exam Findings
Intervention Description
Findings found on clinical exam of a patient the radiologist will be reading CT scans of.
Intervention Type
Other
Intervention Name(s)
Inaccurate Clinical Exam Findings
Intervention Description
Inaccurate findings are given to the radiologists
Intervention Type
Other
Intervention Name(s)
No clinical exam findings
Intervention Description
No clinical exam findings are given to the radiologists
Primary Outcome Measure Information:
Title
Hernia detected on CT
Description
proportion of hernias detected on CT
Time Frame
CT taken within 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants are radiologists at LBJ Hospital.
Facility Information:
Facility Name
UT Health at Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30430273
Citation
Cherla DV, Bernardi K, Blair KJ, Chua SS, Hasapes JP, Kao LS, Ko TC, Matta EJ, Moses ML, Shiralkar KG, Surabhi VR, Tammisetti VS, Viso CP, Liang MK. Importance of the physical exam: double-blind randomized controlled trial of radiologic interpretation of ventral hernias after selective clinical information. Hernia. 2019 Oct;23(5):987-994. doi: 10.1007/s10029-018-1856-3. Epub 2018 Nov 14.
Results Reference
derived
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CT and Radiologist RCT
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