Clinical trial NCT04591145: Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System
Official title: Validation of a Deep Learning Based Bowel Preparation Evaluation System: A Prospective, Multi-center, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenoma
Bowel Preparation
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: Hubei Hospital of Traditional Chinese Medicine
name: Wuhan Central Hospital
name: Wuhan Third Hospital
name: The General Hospital of Central Theater Command
name: The Third People's Hospital of Hubei Province
name: Wuhan Puren Hospital
name: Wuhan Puai Hospital
name: Tian You Hospital Affiliated to Wuhan University of Science and Technology
name: Wuhan Red Cross Hospital
First posted: 2020-10-19
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Continuous colonoscopy from October to December 2020 will be collected in our participating general hospitals.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cleanliness assessment of different intestinal segment in the artificial intelligence system
timeFrame: 3 Months
measure: Adenoma detection rate
timeFrame: 3 Months
Secondary outcomes:
measure: Advanced adenoma detection rate
timeFrame: 3 Months
measure: Polyps detection rate
timeFrame: 3 Months
measure: The mean number of adenomas per procedure
timeFrame: 3 Months
measure: Detection rate of large, small and diminutive polyps
timeFrame: 3 Months
measure: The mean number of large, small and diminutive polyps per procedure
timeFrame: 3 Months
measure: Detection rate of large, small and diminutive adenomas
timeFrame: 3 Months
measure: The mean number of large, small and diminutive adenomas per procedure
timeFrame: 3 Months
measure: Detection rate of adenoma in different sites
timeFrame: 3 Months
measure: The mean number of adenomas in different sites per procedure
timeFrame: 3 Months
measure: Time of colonoscopic insertion/withdrawal
timeFrame: 3 Months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: