The usefulness of AIM in colonoscopy

JRCT ID: jRCTs061210002

Registered date:16/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Serrated lesion
• Date of first enrollment: 28/04/2021
• Target sample size: 1311
• Study type: Interventional
• Intervention(s): Randomized controlled trial

Outcome(s)

• Primary Outcome: Additional effect of AIM on detection of colonic serrated lesions including SSL

Secondary Outcome

(1) Addirional effect of each group for detection of colorectal polyps
(2) Additional effect of each group for detection of colorectal adenoma
(3) Additional effect of each group for detection of SSL
(4) Factors contributing to the additional effect of each group
(5) Differences in additional effect among endoscopists
(6) Treatment time
(7) Incidental disease (posterior bleeding, perforation, and adverse events associated with colonoscopy)
(8) Percentage of colorectal adenomas and colonic serrated lesions in the right side colon

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

(1) Patients who are between 20 years and 90 years old at the time of obtaining consent
(2) A person for whom the patient's written consent has been obtained
(3) Patients who are scheduled for screening colonoscopy (e.g., fecal occult blood, cancer screening, and colonoscopy with no endoscopic treatment within 1 year)

Exclude criteria

(1) Familial colorectal adenomatosis, Lynch syndrome, serrated polyp syndrome(SPS)
(2) Patients with a history of colorectal cancer surgery
(3) Patients with endoscopic treatment of the colon within 1 year
(4) Ulcerative colitis and Crohn's disease
(5) Difficulty with endoscopic examination and treatment due to inability to temporarily stop taking antithrombotic or anticoagulant drugs
(6) Patents with an infectious disease that requires systemic treatment
(7) Pregnant and lactating women
(8) Patients with a history of hypersensitivity to indigocarmine or acetic acid
(9) Patients who are deemed unsuitable as research subjects by the principal investigator or sub-researcher

Related Information

• Primary Sponsor: Kinugasa Hideaki