Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Different Operator Experience

Sponsor

Rajavithi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05990218

Collaborator

(none)

240

Enrollment

Location

Arms

36.5

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.

Condition or Disease	Intervention/Treatment	Phase
Colon Polyp	Device: Artificial intellegence. CADe syste, Device: control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients randomized to 4 arms: control with experienced operator, control with beginner operator, AI with experienced operator, AI with beginner operatorPatients randomized to 4 arms: control with experienced operator, control with beginner operator, AI with experienced operator, AI with beginner operator

Masking:

Single (Participant)

Masking Description:

The patients were masked from being randomized to operator and endoscopic method

Primary Purpose:

Screening

Official Title:

Efficacy of Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Operators With Different Endoscopic Experience: A Randomized Control Trial

Actual Study Start Date :

Feb 13, 2023

Anticipated Primary Completion Date :

Feb 12, 2026

Anticipated Study Completion Date :

Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control, experienced Patients received colonoscopy with double insertion of right sided colon under white light by experienced endoscopist	Device: control The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.
Active Comparator: control, beginner Patients received colonoscopy with double insertion of right sided colon under white light by beginner endoscopist	Device: control The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.
Experimental: AI, experience Patients received colonoscopy with double insertion of right sided colon under AI by experienced endoscopist	Device: Artificial intellegence. CADe syste, The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.
Experimental: AI, beginner Patients received colonoscopy with double insertion of right sided colon under AI by beginner endoscopist	Device: Artificial intellegence. CADe syste, The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.

Outcome Measures

Primary Outcome Measures

polyp detection rate [during endoscopy]
the number of polyp detected during endoscopy

Secondary Outcome Measures

type of polyp [during endoscopy]
the type of polyp detected during endoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

participants age 40-80 years

Exclusion Criteria:

History of colonic surgery (except appendectomy)
Lower gastrointestinal bleeding
unstable vital sign during endoscopy of pregnancy
history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure