Back to resultsThe Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
Primary Purpose
Gastrointestinal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AI generated report
physicians writing report
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Disease focused on measuring Endoscopic Report, Artificial Intelligence, Gastrointestinal Disease, Writing Efficiency
Eligibility Criteria
Inclusion Criteria:
- patients aged between 18 and 80 years；
- patients undergoing gastroscopy and colonoscopy examination with anesthesia；
- patients able to give informed consent
Exclusion Criteria:
- patients with the contraindications to endoscopic examination;
- a history of gastrointestinal cancers;
- allergic to anaesthetics in previous medical history;
- the endoscopic procedure cannot be completed due to stenosis, obstruction, solid food or complications of anaesthesia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Artificial Intelligence generating endoscopic report
Physicians writing endoscopic report
Arm Description
In this group, the endoscopic report was generated by artificial intelligence (AI) based on the structured diagnostic report generation system.
In this group, the endoscopic report was writing by physicians.
Outcomes
Primary Outcome Measures
The time spent writing reports
Sum of the time for writing gastroscopic report and colonoscopic report。
Secondary Outcome Measures
Full Information
NCT ID
NCT04275609
First Posted
February 14, 2020
Last Updated
February 18, 2020
Sponsor
Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT04275609
Brief Title
The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
Official Title
The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2020 (Anticipated)
Primary Completion Date
March 20, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
Detailed Description
Digestive endoscopy permits early detection of gastrointestinal diseases and improving the patients' quality of life. However, writing endoscopic report takes a lot of manpower and time, reducing the efficiency of endoscopy. Our center has developed a structured diagnostic report generation system for digestive endoscopy, which can generates the report by artificial intelligence. Here, we compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disease
Keywords
Endoscopic Report, Artificial Intelligence, Gastrointestinal Disease, Writing Efficiency
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Artificial Intelligence generating endoscopic report
Arm Type
Experimental
Arm Description
In this group, the endoscopic report was generated by artificial intelligence (AI) based on the structured diagnostic report generation system.
Arm Title
Physicians writing endoscopic report
Arm Type
Active Comparator
Arm Description
In this group, the endoscopic report was writing by physicians.
Intervention Type
Other
Intervention Name(s)
AI generated report
Intervention Description
After the endoscopic procedure, the physicians click the structured reporting button of computer to automatically complete the report through the structured diagnostic report generation system. The physicians only make minor corrections to the report.
Intervention Type
Other
Intervention Name(s)
physicians writing report
Intervention Description
After the endoscopic procedure, the physicians writing the report in computer according the procedure.
Primary Outcome Measure Information:
Title
The time spent writing reports
Description
Sum of the time for writing gastroscopic report and colonoscopic report。
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients aged between 18 and 80 years；
patients undergoing gastroscopy and colonoscopy examination with anesthesia；
patients able to give informed consent
Exclusion Criteria:
patients with the contraindications to endoscopic examination;
a history of gastrointestinal cancers;
allergic to anaesthetics in previous medical history;
the endoscopic procedure cannot be completed due to stenosis, obstruction, solid food or complications of anaesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zuo, MD,PhD
Phone
15588818685
Email
zuoxiuli@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, MD,PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
We'll reach out to this number within 24 hrs