Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas

A Single-center Study of an AI-assisted Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas Under Colonoscopy

To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.

Study Overview

• Status: Recruiting
• Conditions: Interventional; Prospective; Self Control
• Intervention / Treatment: Diagnostic test: Bowel readiness

• Study Type: Interventional
• Enrollment (Anticipated): 263
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Honggang Yu, PhD; Phone Number: 13871281899; Email: yuhonggang1969@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 027
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Boru Chen, master; Phone Number: 15071054942; Email: 2201017920@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

At least 4 operators were included in this study, and the operating years of colonoscopy were ≥ 5 years, and the number of independent operating cases was ≥ 3000.

Subjects who meet all of the following specific criteria will be considered for participation in the study:

1. Male or female with age ≥ 45 years inclusive;
2. Able to read, understand and sign 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.

Exclusion Criteria:

Subjects who meet any of the following specific criteria will be refused to participate in the study:

1. have a history of drug or alcohol abuse or psychological disorders within 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 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?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bowel readiness

Diagnostic test: Bowel readiness; During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing. During the examination, the recorder should record the time points of the right colon, transverse colon, and left colon, as well as the time of irrigation. If both are considered to be properly, then second colonoscopy was performed immediately. If both results agree or either side agrees that the gut is not well prepared, the review will be carried out within a year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Missed detection rate of ≥5mm adenoma	(≥ 5mm adenoma missed rate, ≥ 5mm AMR) : Each patient will receive two colonoscopy examinations. The ≥ 5mm adenoma that were not detected in the first colonoscopy was define as missed ≥ 5mm adenoma. Numerator is the number of missed detection of ≥5mm adenomas during colonoscopy, and denominator is the total number of ≥ 5mm adenomas receiving colonoscopy.	6 months

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Investigators: Principal Investigator: Honggang Yu, PhD, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): March 20, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: EA-21-006

Drug and device information, study documents

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