Endoscopic Quality Improvement System Study

Adenoma Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654247
• Other study ID #: EA-19-004
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: November 2020
• Source: Renmin Hospital of Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 25, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Gastric Precancerous Condition
• Precancerous Conditions

Intervention

Behavioral:
• Quality audit and feedback
Endoscopists received quality report generated by Endo.Adm.
• Control
None feedback.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.	3 Months
Primary	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	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