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The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04275609
Recruitment Status : Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Tracking Information
First Submitted Date  ICMJE February 14, 2020
First Posted Date  ICMJE February 19, 2020
Last Update Posted Date February 19, 2020
Estimated Study Start Date  ICMJE February 20, 2020
Estimated Primary Completion Date March 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
The time spent writing reports [ Time Frame: Intraoperative ]
Sum of the time for writing gastroscopic report and colonoscopic report。
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
Official Title  ICMJE The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Gastrointestinal Disease
Intervention  ICMJE
  • Other: AI generated report
    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.
  • Other: physicians writing report
    After the endoscopic procedure, the physicians writing the report in computer according the procedure.
Study Arms  ICMJE
  • Experimental: Artificial Intelligence generating endoscopic report
    In this group, the endoscopic report was generated by artificial intelligence (AI) based on the structured diagnostic report generation system.
    Intervention: Other: AI generated report
  • Active Comparator: Physicians writing endoscopic report
    In this group, the endoscopic report was writing by physicians.
    Intervention: Other: physicians writing report
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2020
Estimated Primary Completion Date March 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xiuli Zuo, MD,PhD 15588818685 zuoxiuli@sdu.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04275609
Other Study ID Numbers  ICMJE 2020SDU-QILU-G002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiuli Zuo, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiuli Zuo, MD,PhD Qilu Hospital of Shandong University
PRS Account Shandong University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP