Examining Techniques on Adenoma Miss Rate in Proximal Colon

Not Applicable

• Conditions: Colorectal Adenoma; Colorectal Polyp

• Registration Number: NCT03355443
• Lead Sponsor: Changhai Hospital

Brief Summary

The primary aim of this study is

- to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon.

Other aims include to explore the data below when re-examination or retroflexion is used.

* Adenoma detection rate, ADR

* Polyp miss rate, PMR

* Polyp detection rate, PDR

* Withdrawal time, WT

Detailed Description

AMR = number of adenomas missing during the first examination/ total number of adenomas in both examinations = number of adenomas detected only in the second examination/(number of adenomas detected during the first examination + number of adenomas detected only in the second examination)

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-28
• Last Update Posted: 2017-11-28
• Study Start: 2017-12
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients between 45 and 80 years who undergo colonoscopy examination for screening, and who receive primary screening and get positive result

Exclusion Criteria

• Pregnant female patients
• Patients received colonoscopy in the past 5 years
• Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
• Patients who had previous abdominal surgery
• Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
• Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
• Patients who have inadequate bowel preparation
• Patients who reject to participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adenoma miss rate in the proximal colon (AMR)	At the end of the procedure, up to 1 hour	AMR refers to the rate of adenoma missing, calculated as the proportion of adenomas which are missing in the first examination. AMR in the proximal colon is calculated with only the proximal colon concerned.

Secondary Outcome Measures

Name	Time	Method
Adenoma Detection Rate in the proximal colon (ADR)	At the end of the procedure, up to 1 hour	ADR refers to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. ADR in the proximal colon is calculated with only the proximal colon concerned.

Trial Locations

Locations (3)

the Sixth affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, China

Tianjin Renmin Hospital; 🇨🇳 Tianjin, China