Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection

Shandong University

Status: Unknown

Conditions: Colonoscopy

Treatments: Device: Computer-aided Real-time Automatic Quality Control System (AQCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04901130

2021SDU-QILU-066

Details and patient eligibility

About

The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.

Full description

We carried a multicenter randomised controlled trial to assess the performance of this system in quality control of real-time colonoscopy, including the adenoma detection rate (ADR), withdraw time, adequate bowel preparation rate and other indicators.

Enrollment: 1,254 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.

Exclusion criteria

• Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
• Patients with a history of colorectal surgery.
• Patients with a contraindication for biopsy.
• Patients with prior failed colonoscopy.
• Patients with known stenosis or obstruction.
• Patients in pregnancy or lactation phase.
• Patients refused to participate in the trial.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,254 participants in 2 patient groups

AQCS-aided group

Experimental group

Description:

Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS.

Treatment:

Device: Computer-aided Real-time Automatic Quality Control System (AQCS)

Control group

No Intervention group

Description:

Patients in control group will go through conventional standard colonoscopy examination without the assistance of the AQCS.