Endoscopic Quality Improvement System Study

NCT04654247 | Completed

• 1 other identifier: EA-19-004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoma Colon; Gastric Precancerous Condition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adcanced ADR

  3 months

Study Arms (2)

Control group

SHAM COMPARATOR

Endoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent.

Behavioral: Control

Feedback group

EXPERIMENTAL

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

Interventions

Quality audit and feedback BEHAVIORAL

Endoscopists received quality report generated by Endo.Adm.

Feedback group

Control BEHAVIORAL

None feedback.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: April 20, 2019
• Primary Completion: August 20, 2019
• Study Completion: November 25, 2019
• Last Updated: December 4, 2020

Record last verified: 2020-11

Locations

CN (1)