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

NCT05444166 | Unknown

• 1 other identifier: EA-22-020
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonoscopy; Artificial Intelligence; Gastrointestinal Disease; Deep Learning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• The polyp detection rate (PDR)

  A month

• The mean number of polyps per patient (MNP)

  A month

• The mean number of adenomas per patient (MAP)

  A month

• colonoscopy withdrawal time

  A month

• colonoscopy forward time

  A month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female ≥18 years old;
• Able to read, understand and sign an informed consent;
• 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;
• Patients requiring screening colonoscopy.

You may not qualify if:

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

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital

Hubei, Wuhan, Hubei, 430000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient colonoscopy videos, photo documentation and pathological section

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Honggang Yu, Doctor

CONTACT

8613871281899; yuhonggang@whu.edu.cn

Chaijie Luo, Doctor

CONTACT

8619828616210; 937648081@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: July 29, 2022
• Primary Completion: October 29, 2023
• Study Completion: November 29, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)