Endoscopic Quality Improvement System Study

A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy

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.

Study Overview

• Status: Completed
• Conditions: Adenoma Colon; Gastric Precancerous Condition
• Intervention / Treatment: Behavioral: Control; Behavioral: Quality audit and feedback

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Endoscopist:

1. Endoscopist with more than one year experience in gastrointestinal mirror operation;
2. Willing to further improve endoscopic quality through Endo.Adm feedback;
3. 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:

1. Have participated in other clinical trials;
2. Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations;
3. Endoscopist who were either not present for both parts (phase1 and phase2) of the study.

Patients:

Colonoscopy:

1. Polyposis syndromes
2. Lumen obstruction
3. History of colorectal surgery
4. History of colorectal surgery

Gastroscopy:

1. Obstruction
2. History of gastric surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; Endoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent.	Behavioral: Control; None feedback.
Experimental: Feedback group; 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.	Behavioral: Quality audit and feedback; Endoscopists received quality report generated by Endo.Adm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.	3 Months
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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2019
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Precancerous Conditions
• Other Study ID Numbers: EA-19-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No