Velidation research of colonoscopy using artificial intelligence

JRCT ID: jRCT1030220081

Registered date:28/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neoplastic polyp of the colon and rectum
• Date of first enrollment: 06/01/2021
• Target sample size: 400
• Study type: Interventional
• Intervention(s): We enrolled 415 subjects who under went colonoscopy at our institution from January 2021 to March 2022.The randomization method used in this study was the numbered container method according to the CONSORT guideline. The allocation message was generated by the computer program of the Python random module and then sealed in sequentially numbered identical containers according to the allocation sequence. After an eligibility check, the endoscopist opened theallocation message, and subsequently, examinees were randomly assigned to the CADe or control groups.

Outcome(s)

• Primary Outcome: Adenoma detection rate in total colonoscopy
• Secondary Outcome: Adenoma miss rate in recto-sigmoid scopy

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: <= 81age old
• Gender: Both
• Include criteria: Colorectal cancer screening endoscopy, colonoscopy after fecal occult blood positive test, surveillance after colorectal polyp resection
• Exclude criteria: After colorectal surgery or inflammatory bowel disease

Related Information

• Primary Sponsor: Nakashima Hirotaka