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

Not Applicable

• Conditions: Colonoscopy
• Interventions: Device: Computer-aided Real-time Automatic Quality Control System (AQCS)

• Registration Number: NCT04901130
• Lead Sponsor: Shandong University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Last Update Submitted: 2021-05-24
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25
• Study Start: 2021-05-27
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1254

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AQCS-aided group	Computer-aided Real-time Automatic Quality Control System (AQCS)	Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS.

Primary Outcome Measures

Name	Time	Method
Colorectal adenoma detection rate (ADR)	10 months	The primary endpoint is the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected by colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Colorectal polyp detection rate (PDR)	10 months	The polyp detection rate (PDR) is the proportion of patients having one or more polyps detected by colonoscopy.
Withdrawl time	During procedure	Withdrawl time is defined as the time taken to remove the colonoscope from the cecal pole minus the time of therapeutic interventions or biopsy, until the complete withdrawal of the colonoscope.
The mean number of adenomas detected per colonoscopy (APC)	10 months	The mean number of adenomas detected per colonoscopy in AQCS and control groups
The mean number of polyps detected per colonoscopy (PPC)	10months	The mean number of polyps detected per colonoscopy in AQCS and control groups

Trial Locations

Locations (6)

Binzhou Medical University Hospital; 🇨🇳 Binzhou, Shandong, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Central Hospital of Shengli Oilfield; 🇨🇳 Dongying, Shandong, China

Linyi People's Hospital; 🇨🇳 Dezhou, Shandong, China

The People's Hospital of Zhaoyuan City; 🇨🇳 Yantai, Shandong, China

Zibo Municipal Hospital; 🇨🇳 Zibo, Shandong, China