AI-assisted Colonoscopy Report System In Improving Reporting Quality

Not Applicable

Not yet recruiting

• Conditions: Artificial Intelligence; Colonoscopy
• Interventions: Diagnostic Test: Artificial intelligence assistant system

• Registration Number: NCT05829590
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

In this study, the investigators proposed a prospective study about the effectiveness of speech and image recognition-based system in improving reporting quality during colonoscopy for colonoscopy report quality in endoscopists. The participants would be divided into two groups. For the collected colonoscopy videos, group A would record their observations with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions. Group B would complete the endoscopy report without special prompts. After a period of washout period, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the colonoscopy report. Then, the completeness of the colonoscopy report, the completeness of capturing anatomical landmarks and detected lesions, the completeness of structured description, the accuracy of lesion reporting, the time for reporting and the satisfaction with the reporting system are compared with or without AI assistance.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Study Start: 2023-05-15
• Primary Completion: 2023-06-15
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients:

1. Male or female ≥18 years old;
2. Able to read, understand and sign an informed consent;
3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
4. Patients requiring colonoscopy.

Doctors:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtaining the Physician's Practice License.

Exclusion Criteria

Patients:

1. Have drug or alcohol abuse or mental disorder in the last 5 years;
2. Pregnant or lactating women;
3. Patients with known multiple polyp syndrome;
4. patients with known inflammatory bowel disease;
5. known intestinal stenosis or space-occupying tumor;
6. known colon obstruction or perforation;
7. patients with a history of colorectal surgery;
8. Patients with a previous history of allergy to pre-used spasmolysis;
9. Unable to perform biopsy due to coagulation disorders or oral anticoagulants;
10. High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Doctors:

1. The researcher believes that the subjects are not suitable for participating in clinical trials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
with Artificial intelligence assistant system	Artificial intelligence assistant system	Endoscopists would complete the colonoscopy report with the assistance of the artificial intelligence system.

Primary Outcome Measures

Name	Time	Method
The integrity of colonoscopy report	One month	Report integrity with or without AI-assisted. Calculation method = number of information recorded / total number of information need to record x 100%

Secondary Outcome Measures

Name	Time	Method
The integrity of capturing anatomical landmarks	One month	The integrity in captured bowel landmrak images with or without AI-assisted. Calculation method = number of anatomical landmarks in captured images / total number of anatomical landmarks x 100%

Trial Locations

Locations (1)

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