Clinical trial NCT03355443: Examining Techniques on Adenoma Miss Rate in Proximal Colon
Official title: Efficacy of Segmental Re-examination and Retroflexion of Proximal Colon for Adenoma Miss Rate During Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Polyp
Keywords: Colonoscopy
Lower Gastrointestinal Tract
Re-examination
Retroflexion
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma miss rate in the proximal colon (AMR)
timeFrame: At the end of the procedure, up to 1 hour
Secondary outcomes:
measure: Adenoma Detection Rate in the proximal colon (ADR)
timeFrame: At the end of the procedure, up to 1 hour
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
city: Tianjin
country: China
facility: Tianjin Renmin Hospital
Study officials:
References:
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 adenoma detection: a comparison study. Am J Gastroenterol. 2015 Mar;110(3):415-22. doi: 10.1038/ajg.2015.21. Epub 2015 Mar 3.
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.
citation: 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.