Back to resultsEndoscopic Quality Improvement System Study
Primary Purpose
Adenoma Colon, Gastric Precancerous Condition
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Quality audit and feedback
Control
Sponsored by
About this trial
This is an interventional health services research trial for Adenoma Colon
Eligibility Criteria
Inclusion Criteria:
Endoscopist:
- Endoscopist with more than one year experience in gastrointestinal mirror operation;
- Willing to further improve endoscopic quality through Endo.Adm feedback;
- Ability to read, understand and sign informed consent; The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all research procedures and follow-up visits in conjunction with the research process.
Exclusion Criteria:
Endoscopist:
- Have participated in other clinical trials;
- Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations;
- Endoscopist who were either not present for both parts (phase1 and phase2) of the study.
Patients:
Colonoscopy:
- Polyposis syndromes
- Lumen obstruction
- History of colorectal surgery
- History of colorectal surgery
Gastroscopy:
- Obstruction
- History of gastric surgery
Sites / Locations
- Renmin Hospital of Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control group
Feedback group
Arm Description
Endoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent.
Endoscopists in feedback group were informed standard quality indicators requirements and the corresponding references during informed consent. In addition to the quality requirements, endoscopists randomized to feedback group received customized quality reports feedback from Endo.Adm weekly.
Outcomes
Primary Outcome Measures
Adenoma detection rate
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Gastric precancerous detection rate
GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.
Secondary Outcome Measures
Adcanced ADR
Adcanced ADR was calculated by dividing the total number of patients being detected ≥10mm in size, or adenomas with histopathology of tubulovillous, villous, adenocarcinoma, or high-grade dysplasia by the number of colonoscopies.
Full Information
NCT ID
NCT04654247
First Posted
November 27, 2020
Last Updated
November 27, 2020
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT04654247
Brief Title
Endoscopic Quality Improvement System Study
Official Title
A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a practical basis for improving the quality of digestive endoscopy in our endoscopic center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon, Gastric Precancerous Condition
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Endoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent.
Arm Title
Feedback group
Arm Type
Experimental
Arm Description
Endoscopists in feedback group were informed standard quality indicators requirements and the corresponding references during informed consent. In addition to the quality requirements, endoscopists randomized to feedback group received customized quality reports feedback from Endo.Adm weekly.
Intervention Type
Behavioral
Intervention Name(s)
Quality audit and feedback
Intervention Description
Endoscopists received quality report generated by Endo.Adm.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
None feedback.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Time Frame
3 Months
Title
Gastric precancerous detection rate
Description
GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Adcanced ADR
Description
Adcanced ADR was calculated by dividing the total number of patients being detected ≥10mm in size, or adenomas with histopathology of tubulovillous, villous, adenocarcinoma, or high-grade dysplasia by the number of colonoscopies.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Endoscopist:
Endoscopist with more than one year experience in gastrointestinal mirror operation;
Willing to further improve endoscopic quality through Endo.Adm feedback;
Ability to read, understand and sign informed consent; The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all research procedures and follow-up visits in conjunction with the research process.
Exclusion Criteria:
Endoscopist:
Have participated in other clinical trials;
Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations;
Endoscopist who were either not present for both parts (phase1 and phase2) of the study.
Patients:
Colonoscopy:
Polyposis syndromes
Lumen obstruction
History of colorectal surgery
History of colorectal surgery
Gastroscopy:
Obstruction
History of gastric surgery
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual de-identified participant data that underlie the results reported in this article and study protocol will be shared for investigators whose proposed use of the data has been approved by an independent review committee. Data can only be used to achieve aims in the approved proposal. Data disclosure begins 9 months and ends 36 months after article publication. To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.
Learn more about this trial
Endoscopic Quality Improvement System Study
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