Endoscopic Quality Improvement System Study

Not Applicable

Completed

• Conditions: Adenoma Colon; Gastric Precancerous Condition

• Registration Number: NCT04654247
• Lead Sponsor: Renmin Hospital of Wuhan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-20
• Primary Completion: 2019-08-20
• Study Completion: 2019-11-25
• Status Verified: 2020-11
• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Last Update Submitted: 2020-11-27
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gastric precancerous detection rate	3 Months	GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.
Adenoma detection rate	3 Months	ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.

Secondary Outcome Measures

Name	Time	Method
Adcanced ADR	3 months	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.

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China