Examining Techniques on Adenoma Miss Rate in Proximal Colon

Colorectal Adenoma Clinical Trial

— SINOCOLO2017  

Official title:

Efficacy of Segmental Re-examination and Retroflexion of Proximal Colon for Adenoma Miss Rate During Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03355443
• Other study ID #: SINOCOLO2017
• Secondary ID: 2017YFC1308802
• Status: Not yet recruiting
• Phase: N/A
• First received: November 22, 2017
• Last updated: November 22, 2017
• Start date: December 2017
• Est. completion date: December 2019

Study information

• Verified date: November 2017
• Source: Changhai Hospital
• Contact: En-Da YU, MBBS
• Phone: 08618699629177
• Email: endayu[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Polyp

Intervention

Procedure:
• Retroflexion
Retroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum.
• Re-examination
Re-examination in colonoscopy means examining the cecum and ascending colon twice in the routine fashion.

Locations

Country	Name	City	State
China	the Sixth affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Zhongshan Hospital affiliated to Fudan University	Shanghai
China	Tianjin Renmin Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15. — View Citation

Kushnir VM, Oh YS, Hollander T, Chen CH, Sayuk GS, Davidson N, Mullady D, Murad FM, Sharabash NM, Ruettgers E, Dassopoulos T, Easler JJ, Gyawali CP, Edmundowicz SA, Early DS. Impact of retroflexion vs. second forward view examination of the right colon on — View Citation

Lee HS, Jeon SW, Park HY, Yeo SJ. Improved detection of right colon adenomas with additional retroflexion following two forward-view examinations: a prospective study. Endoscopy. 2017 Apr;49(4):334-341. doi: 10.1055/s-0042-119401. Epub 2016 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma miss rate in the proximal colon (AMR)	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.	At the end of the procedure, up to 1 hour
Secondary	Adenoma Detection Rate in the proximal colon (ADR)	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.	At the end of the procedure, up to 1 hour