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The 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
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 14, 2020
    Last Updated
    February 18, 2020
    Sponsor
    Shandong University
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    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

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