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

Not Applicable

• Conditions: Self Control; Prospective; Interventional
• Interventions: Diagnostic Test: Bowel readiness

• Registration Number: NCT05145712
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-20
• Study Start: 2021-07-21
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06
• Primary Completion: 2022-01-30
• Study Completion: 2022-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 263

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bowel readiness	Bowel readiness	-

Primary Outcome Measures

Name	Time	Method
Missed detection rate of ≥5mm adenoma	6 months	(≥ 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.

Trial Locations

Locations (1)

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