Examining Techniques on Adenoma Miss Rate in Proximal Colon

NCT ID: NCT03355443

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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)

Conditions

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Colorectal Adenoma Colorectal Polyp

Keywords

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Colonoscopy Lower Gastrointestinal Tract Re-examination Retroflexion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Re-examination Group

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.

Group Type ACTIVE_COMPARATOR

Re-examination

Intervention Type PROCEDURE

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

Retroflexion Group

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.

Group Type EXPERIMENTAL

Retroflexion

Intervention Type PROCEDURE

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

Interventions

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Retroflexion

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

Intervention Type PROCEDURE

Re-examination

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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En-Da Yu

Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Sixth affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Zhongshan Hospital affiliated to Fudan University

Shanghai, , China

Site Status

Tianjin Renmin Hospital

Tianjin, , China

Site Status

Countries

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China

Central Contacts

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En-Da YU, MBBS

Role: CONTACT

Phone: 08618699629177

Email: [email protected]

Zi-Ye ZHAO, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Chu-Jun LI, MBBS

Role: primary

Ping-Hong ZHOU, MD

Role: primary

Wen LI

Role: primary

References

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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.

Reference Type RESULT
PMID: 25732415 (View on PubMed)

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.

Reference Type RESULT
PMID: 27931050 (View on PubMed)

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.

Reference Type RESULT
PMID: 21679946 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37653767 (View on PubMed)

Other Identifiers

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2017YFC1308802

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SINOCOLO2017

Identifier Type: -

Identifier Source: org_study_id