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

NCT ID: NCT05145712

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2022-03-20

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.

Conditions

Self Control; Prospective; Interventional

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Bowel readiness

Group Type: EXPERIMENTAL

Bowel readiness

Intervention Type: DIAGNOSTIC_TEST

During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing.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

Interventions

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During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing.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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Yu Honggang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Honggang Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Honggang Yu, PhD

Role: CONTACT

Phone: 13871281899

Email: yuhonggang1969@163.com

Facility Contacts

Boru Chen, master

Role: primary

References

Yao L, Xiong H, Li Q, Wang W, Wu Z, Tan X, Luo C, You H, Zhang C, Zhang L, Lu Z, Yu H, Chen H. Validation of artificial intelligence-based bowel preparation assessment in screening colonoscopy (with video). Gastrointest Endosc. 2024 Oct;100(4):728-736.e9. doi: 10.1016/j.gie.2024.04.015. Epub 2024 Apr 16.

Reference Type: DERIVED

PMID: 38636818 (View on PubMed)

Other Identifiers

EA-21-006

Identifier Type: -

Identifier Source: org_study_id