Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System

• Conditions: Bowel Preparation; Adenoma
• Interventions: Other: Observational group

• Registration Number: NCT04591145
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

A deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase has been constructed previously. This multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion.

Detailed Description

Inadequate bowel preparation is insufficient for identification of polyps greater than 5 mm. However, bowel preparation assessment involved subjectivity and uncertainty. We constructed a deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase and performed a prospective observational study to validate the threshold of the adequate proportion.The multi-center study is aimed to verify the extrapolation and robustness of the scoring threshold based on artificial intelligence intestinal cleanliness evaluation system explored in the early stage, and propose a more accurate and quantifiable threshold for evaluating the eligibility of intestinal preparation.

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-09
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-12
• Last Update Submitted: 2020-10-12
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Male or female aged 18 years or above;
• Ability to read, understand and sign informed consent forms;
• The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.

Exclusion Criteria

• Patients with contraindications to colonoscopy (obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, severe heart failure, etc.);
• Patients with galactosemia;
• Pregnant or lactating women;
• Patients used lactulose, a stimulant, or laxative within 7 days;
• Patients refused to sign informed consent forms.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	Observational group	Patients received bowel preparation and colonoscopy. The withdrawal phase video was saved and their lesions detection was record.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	3 Months	The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Cleanliness assessment of different intestinal segment in the artificial intelligence system	3 Months	The Artificial intelligence evaluates the Boston Bowel Preparation score of the ascending colon, transverse colon and descending colon in real-time, and calculates the proportion of 0-1 Score

Secondary Outcome Measures

Name	Time	Method
The mean number of large, small and diminutive polyps per procedure	3 Months	The numerator was the number of large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Detection rate of adenoma in different sites	3 Months	The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Advanced adenoma detection rate	3 Months	The numerator is the number of cases of advanced adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Polyps detection rate	3 Months	The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
The mean number of adenomas per procedure	3 Months	The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy
Detection rate of large, small and diminutive polyps	3 Months	The numerator was the number of patients with large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Detection rate of large, small and diminutive adenomas	3 Months	The numerator was the number of patients with large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
The mean number of large, small and diminutive adenomas per procedure	3 Months	The numerator was the number of large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
The mean number of adenomas in different sites per procedure	3 Months	The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time of colonoscopic insertion/withdrawal	3 Months	The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening and the duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.

Trial Locations

Locations (1)

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