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Endoscopic Quality Improvement System Study

Sponsor
Renmin Hospital of Wuhan University (Other)
Overall Status
Completed
CT.gov ID
NCT04654247
Collaborator
(none)
17
Enrollment
1
Location
2
Arms
7.2
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Quality audit and feedback
  • Behavioral: Control
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy
Actual Study Start Date :
Apr 20, 2019
Actual Primary Completion Date :
Aug 20, 2019
Actual Study Completion Date :
Nov 25, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adenoma detection rate [3 Months]

    ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.

  2. 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.

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renmin Hospital of Wuhan University Wuhan Hubei China 430000

Sponsors and Collaborators

  • Renmin Hospital of Wuhan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier:
NCT04654247
Other Study ID Numbers:
  • EA-19-004
First Posted:
Dec 4, 2020
Last Update Posted:
Dec 4, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenoma
Precancerous Conditions

Study Results

No Results Posted as of Dec 4, 2020