Examining Techniques on Adenoma Miss Rate in Proximal Colon

NCT03355443 | Unknown

• 2 other identifiers: SINOCOLO20172017YFC1308802
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

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

Conditions

Colorectal Adenoma; Colorectal Polyp

Keywords

Colonoscopy; Lower Gastrointestinal Tract; Re-examination; Retroflexion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adenoma Detection Rate in the proximal colon (ADR)

  At the end of the procedure, up to 1 hour

Study Arms (2)

Re-examination Group

ACTIVE COMPARATOR

Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined in the same fashion. After that, the rest of the colon is examined in routine method.

Procedure: Re-examination

Retroflexion Group

EXPERIMENTAL

Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined with the colonoscope tip in reverse direction (retroflexion fashion). After that, the rest of the colon is examined in routine method.

Procedure: Retroflexion

Interventions

Retroflexion PROCEDURE

Retroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum.

Retroflexion Group

Re-examination PROCEDURE

Re-examination in colonoscopy means examining the cecum and ascending colon twice in the routine fashion.

Re-examination Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (3)

the Sixth affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

Zhongshan Hospital affiliated to Fudan University

Shanghai, 200032, China

Location

Tianjin Renmin Hospital

Tianjin, 300121, China

Location

Related Publications (4)

• 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.

  PMID: 25732415 RESULT

• 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.

  PMID: 27931050 RESULT

• 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.

  PMID: 21679946 RESULT

• Wang CL, Zhao ZY, Wu JY, Yan FH, Yuan J, Xing JJ, Wang H, Yu ED. Efficacy of cecal retroflexion observed on adenoma missing of ascending colon during colonoscopy: A prospective, randomized, pilot trial. Medicine (Baltimore). 2023 Aug 25;102(34):e34806. doi: 10.1097/MD.0000000000034806.

  PMID: 37653767 DERIVED

Central Study Contacts

En-Da YU, MBBS

CONTACT

08618699629177; endayu@yeah.net

Zi-Ye ZHAO, MD

CONTACT

yemenzhao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

CN (3)