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Completed

NCT Number: NCT04654247

Endoscopic Quality Improvement System Study

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.

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Key information

Conditions

Adenoma Colon Gastric Precancerous Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Quality audit and feedback

Behavioral

Endoscopists received quality report generated by Endo.Adm.

Control

Behavioral

None feedback.

Primary outcomes

  1. Adenoma detection rate

    Time frame: 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

    Time frame: 3 Months

    GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.

Secondary outcomes

  1. Adcanced ADR

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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