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

NCT05145712 | Unknown

• 1 other identifier: EA-21-006
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bowel readiness

EXPERIMENTAL

Diagnostic Test: Bowel readiness

Interventions

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During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing.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

Bowel readiness

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who meet any of the following specific criteria will be refused to participate in the study:
• have a history of drug or alcohol abuse or psychological disorders within 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 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 of Wuhan University

Wuhan, Hubei, 027, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38636818 DERIVED

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Honggang Yu, PhD

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Honggang Yu, PhD

CONTACT

13871281899; yuhonggang1969@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: December 6, 2021
• Study Start: July 21, 2021
• Primary Completion: January 30, 2022
• Study Completion: March 20, 2022
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

CN (1)