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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Artificial Intelligence; Colonoscopy; Gastrointestinal Disease; Deep Learning

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

• Study Contact: Name: Chaijie Luo, Doctor; Phone Number: 8619828616210; Email: 937648081@qq.com
• Study Contact Backup: Name: Honggang Yu, Doctor; Phone Number: 8613871281899; Email: yuhonggang@whu.edu.cn

Study Locations

• China
  • Wuhan, Hubei
    • Hubei, Wuhan, Hubei, China, 430000
      • Recruiting
      • Renmin Hospital
      • Contact: Chaijie Luo, Doctor; Phone Number: 8619828616210; Email: 937648081@qq.com
      • Contact: Honggang Yu, Doctor; Phone Number: 8613871281899; Email: yuhonggang@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In this study, endoscopists who completed at least 140 colonoscopies were selected as the research objects, and patients who met the criteria were included in the experiment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
colonoscopy withdrawal time	The time is taken to finish the examination from the beginning of the ileocecal region.	A month
colonoscopy forward time	The time is taken to go from the rectum to the ileocecal region.	A month

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Anticipated): October 29, 2023
• Study Completion (Anticipated): November 29, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: EA-22-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No