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Examining Techniques on Adenoma Miss Rate in Proximal Colon (SINOCOLO2017)

Primary Purpose

Colorectal Adenoma, Colorectal Polyp

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Retroflexion

Re-examination

About this trial

This is an interventional prevention trial for Colorectal Adenoma focused on measuring Colonoscopy, Lower Gastrointestinal Tract, Re-examination, Retroflexion

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

the Sixth affiliated Hospital of Sun Yat-Sen University
Zhongshan Hospital affiliated to Fudan University
Tianjin Renmin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Re-examination Group

Retroflexion Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03355443

First Posted

November 22, 2017

Last Updated

November 22, 2017

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03355443

Brief Title

Examining Techniques on Adenoma Miss Rate in Proximal Colon

Acronym

SINOCOLO2017

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2017 (Anticipated)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Adenoma, Colorectal Polyp

Keywords

Colonoscopy, Lower Gastrointestinal Tract, Re-examination, Retroflexion

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Re-examination Group

Arm Type

Active Comparator

Arm Description

Arm Title

Retroflexion Group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Retroflexion

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Re-examination

Intervention Description

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

Primary Outcome Measure Information:

Title

Adenoma miss rate in the proximal colon (AMR)

Description

Time Frame

At the end of the procedure, up to 1 hour

Secondary Outcome Measure Information:

Title

Adenoma Detection Rate in the proximal colon (ADR)

Description

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.

Time Frame

At the end of the procedure, up to 1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

En-Da YU, MBBS

Phone

08618699629177

endayu@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

Zi-Ye ZHAO, MD

yemenzhao@126.com

Facility Information:

Facility Name

the Sixth affiliated Hospital of Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chu-Jun LI, MBBS

Phone

8602038777676

Facility Name

Zhongshan Hospital affiliated to Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ping-Hong ZHOU, MD

Facility Name

Tianjin Renmin Hospital

City

Tianjin

ZIP/Postal Code

300121

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wen LI

12. IPD Sharing Statement

Citations:

PubMed Identifier

25732415

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. Erratum In: Am J Gastroenterol. 2015 Jun;110(6):942.

Results Reference

result

PubMed Identifier

27931050

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.

Results Reference

result

PubMed Identifier

21679946

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.

Results Reference

result

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Examining Techniques on Adenoma Miss Rate in Proximal Colon

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