Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the ADR

Colonoscopy Clinical Trial

Official title:

Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the Adenoma Detection Rate: a Prospective, Multicenter, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444166
• Other study ID #: EA-22-020
• Status: Recruiting
• Start date: July 29, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: March 2023
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, Doctor
• Phone: 8613871281899
• Email: yuhonggang[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it based on optical flow method and the adenoma detection rate.

Description:

Study showed that adequate withdrawal time is an important prerequisite for full mucosal inspection. In a large population-based analysis, a 1-min increase in withdrawal time led to a 3.6% increase in the ADR. Protocols or expert consensus recommend a standard withdrawal time of 6 min or longer. However, Findings of studies showed that a number of colonoscopies had a withdrawal time less than 6 min, which greatly reduces the ADR. Investigator's preliminary experiments have shown that deep learning can monitor the colonoscopy withdrawal time in real-time and improve the adenoma detection rate. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy withdrawal assessment system. The investigators improved EndoAngel to use optical flow method to monitor the colonoscopy withdrawal speed. The performance of the EndoAngel system was verified in colonoscopy videos. The investigators then aimed to evaluate whether the EndoAngel system could improve polyp detection rate after restricting the colonoscopy withdrawal speed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: November 29, 2023
• Est. primary completion date: October 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 screening colonoscopy.

Exclusion Criteria:

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 and polyp removal 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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Colonoscopy
• Deep Learning
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Locations

Country	Name	City	State
China	Renmin Hospital	Hubei	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	The adenoma detection rate (ADR)	ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.	A month
Primary	The percentage of colonoscopy withdrawal overspeed	The percentage of colonoscopy withdrawal overspeed was calculated by dividing the time of colonoscopy withdrawal overspeed by the total time of colonoscopy withdrawal.	A month
Secondary	The polyp detection rate (PDR)	PDR was calculated by dividing the total number of patients being detected polyps by the number of colonoscopies.	A month
Secondary	The mean number of polyps per patient (MNP)	MNP was calculated by dividing the total number of polyps by the number of colonoscopies.	A month
Secondary	The mean number of adenomas per patient (MAP)	MAP was calculated by dividing the total number of adenomas by the number of colonoscopies.	A month
Secondary	colonoscopy withdrawal time	The time is taken to finish the examination from the beginning of the ileocecal region.	A month
Secondary	colonoscopy forward time	The time is taken to go from the rectum to the ileocecal region.	A month