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Impact of SE of the Proximal Colon on the AMR

Primary Purpose

Adenoma Miss Rate

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
second examination of the proximal colon
Sponsored by
Third People's Hospital of Jingdezhen City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoma Miss Rate

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Consecutive patients aged 40-75years undergoing colonoscopy for screening Exclusion Criteria: failed cecal intubation, prior colorectal resection, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon), inflammatory bowel disease or intestinal tuberculosis, familial polyposis syndrome, coagulation dysfunction, or polyp retrieval failure.

Sites / Locations

  • Second People's Hospital of Jingdezhen CityRecruiting
  • Third People's Hospital of Jingdezhen CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

conventional examination

second examination

Arm Description

For patients in the CE group, the colonoscope was withdrawn directly from the splenic flexure to the rectum, and polyps that were found were removed

For patients in the SE group, the colonoscope was reinserted into the cecum, additional polyps were removed from the proximal colon during the third withdrawall(third pass), and the remainder of the colon from splenic flexure to rectum was examined in a standard manner

Outcomes

Primary Outcome Measures

proximal AMR
the number of proximal adenomas detected in the second pass(CE group)or the third pass(SE group)divided by the total number of proximal adenomas detected during the tandem colonoscopy.

Secondary Outcome Measures

proximal polyp miss rate
the number of proximal polyps detected in the second pass(CE group)or the third pass(SE group)divided by the total number of proximal polyps detected during the tandem colonoscopy
Per-patient proximal AMR or per-patient proximal PMR
the number of patients in whom proximal adenomas or polyps were detected only in the second pass(CE group)or the third pass(SE group)divided by the total number of patients with at least one proximal adenoma or polyp detected during the tandem colonoscopy
The adenoma detection rate (ADR) or polyp detection rate (PDR)
the proportion of patients with at least one adenoma or polyp detected during the tandem colonoscopy
Adenoma per colonoscopy (APC) or polyp per colonoscopy (PPC)
the total number of adenomas or polyps divided by the total number of patients
proximal advanced AMR(AAMR)
Advanced adenoma is defined as an adenoma with a size ≥10 mm, with tubulovillous or villous histology, or with high-grade dysplasia.

Full Information

First Posted
January 25, 2023
Last Updated
February 15, 2023
Sponsor
Third People's Hospital of Jingdezhen City
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1. Study Identification

Unique Protocol Identification Number
NCT05712304
Brief Title
Impact of SE of the Proximal Colon on the AMR
Official Title
Impact of the Second vs. Conventional Examination of the Proximal Colon on Adenoma Miss Rate, a Prospective Randomized Tandem Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Third People's Hospital of Jingdezhen City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
.Studies have demonstrated that the second examination of the proximal colon can significantly increase the proximal ADR.This study aimed to determine the impact of second examination of the proximal colon on AMR compared to conventional examination.Consecutive patients aged 40-75years undergoing colonoscopy for screening.Tandem withdrawal was used in the proximal colon.Patients were randomly assigned to either the second examination(SE) or the conventional examination(CE) group.The primary outcome measure was proximal AMR,defined as the number of proximal adenomas detected in the second pass(CE group)or the third pass(SE group)divided by the total number of proximal adenomas detected during the tandem colonoscopy.
Detailed Description
Colonoscopy is routinely performed for detection and removal of colorectal adenomas, thereby preventing colorectal cancer(CRC).The adenoma miss rates(AMR) still ranges between 26%-62%,and missed adenomas may contribute to the development of interval CRC.Therefore, there is currently considerable interest in improving AMR during a colonoscopy.The second examination has recently attracted increasing attention.since it only requires a relatively short procedure time and does not require any specialized equipment.Thus, we performed an randomized controlled trial (RCT) in patients undergoing colonoscopy for screening to determine the impact of second examination of the proximal colon on AMR compared to conventional examination. This study aimed to determine the impact of second examination of the proximal colon on AMR compared to conventional examination.Consecutive patients aged 40-75years undergoing colonoscopy for screening.Patients were excluded if they failed cecal intubation, prior colorectal resection, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon), inflammatory bowel disease or intestinal tuberculosis, familial polyposis syndrome, coagulation dysfunction, or polyp retrieval failure. Consecutive patients aged 40-75years undergoing colonoscopy for screening.Tandem withdrawal was used in the proximal colon.The colonoscope was inserted in a standard manner. After successful insertion in the cecum, the colonoscope was slowly withdrawn to the splenic flexure and the mucosa was carefully observed, the polyps that were found were removed for histopathologic examination(first pass).Once the splenic flexure was reached, the position of splenic flexure was marked by creating a suction mark or taking a small biopsy. Subsequently, the colonoscope was advanced to the cecum again, additional polyps were removed from the proximal colon during the second withdrawal(second pass). When the colonoscope completed the two forward view examination of the proximal colon (defined as proximal to the splenic flexure), patients were randomly assigned to either the second examination(SE) or the conventional examination(CE) group. The randomization sequence was computer-generated and concealed in sequentially numbered sealed opaque envelopes, at this moment, the envelope was opened. For patients in the SE group, the colonoscope was reinserted into the cecum, additional polyps were removed from the proximal colon during the third withdrawall(third pass), and the remainder of the colon from splenic flexure to rectum was examined in a standard manner. For patients in the CE group, the colonoscope was withdrawn directly from the splenic flexure to the rectum, and polyps that were found were removed. Multiple diminutive hyperplastic polyps (≤ 5 mm) in the sigmoid colon and rectum were not subjected to removal, and only one representative polyp biopsy was analyzed. We recorded all adverse events at the time of the colonoscopy and for one week there after The cecal intubation time and withdrawal time were recorded by an assistant with a stopwatch. The time for polypectomy and biopsy were excluded from the withdrawal time. The primary outcome measure was proximal AMR,defined as the number of proximal adenomas detected in the second pass(CE group)or the third pass(SE group)divided by the total number of proximal adenomas detected during the tandem colonoscopy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional examination
Arm Type
No Intervention
Arm Description
For patients in the CE group, the colonoscope was withdrawn directly from the splenic flexure to the rectum, and polyps that were found were removed
Arm Title
second examination
Arm Type
Experimental
Arm Description
For patients in the SE group, the colonoscope was reinserted into the cecum, additional polyps were removed from the proximal colon during the third withdrawall(third pass), and the remainder of the colon from splenic flexure to rectum was examined in a standard manner
Intervention Type
Diagnostic Test
Intervention Name(s)
second examination of the proximal colon
Intervention Description
For patients in the SE group, the colonoscope was reinserted into the cecum, additional polyps were removed from the proximal colon during the third withdrawall(third pass), and the remainder of the colon from splenic flexure to rectum was examined in a standard manner
Primary Outcome Measure Information:
Title
proximal AMR
Description
the number of proximal adenomas detected in the second pass(CE group)or the third pass(SE group)divided by the total number of proximal adenomas detected during the tandem colonoscopy.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
proximal polyp miss rate
Description
the number of proximal polyps detected in the second pass(CE group)or the third pass(SE group)divided by the total number of proximal polyps detected during the tandem colonoscopy
Time Frame
2 years
Title
Per-patient proximal AMR or per-patient proximal PMR
Description
the number of patients in whom proximal adenomas or polyps were detected only in the second pass(CE group)or the third pass(SE group)divided by the total number of patients with at least one proximal adenoma or polyp detected during the tandem colonoscopy
Time Frame
2 years
Title
The adenoma detection rate (ADR) or polyp detection rate (PDR)
Description
the proportion of patients with at least one adenoma or polyp detected during the tandem colonoscopy
Time Frame
2 years
Title
Adenoma per colonoscopy (APC) or polyp per colonoscopy (PPC)
Description
the total number of adenomas or polyps divided by the total number of patients
Time Frame
2 years
Title
proximal advanced AMR(AAMR)
Description
Advanced adenoma is defined as an adenoma with a size ≥10 mm, with tubulovillous or villous histology, or with high-grade dysplasia.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Consecutive patients aged 40-75years undergoing colonoscopy for screening Exclusion Criteria: failed cecal intubation, prior colorectal resection, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon), inflammatory bowel disease or intestinal tuberculosis, familial polyposis syndrome, coagulation dysfunction, or polyp retrieval failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaojia zhu
Phone
15879497590
Email
zhuxiaojia2021@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li yang
Organizational Affiliation
Third People's Hospital of Jingdezhen,
Official's Role
Study Director
Facility Information:
Facility Name
Second People's Hospital of Jingdezhen City
City
Jingdezhen
State/Province
Jiangxi
ZIP/Postal Code
333000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fangxi cheng
Phone
13879858019
Facility Name
Third People's Hospital of Jingdezhen City
City
Jingdezhen
State/Province
Jiangxi
ZIP/Postal Code
333000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Zhu
Email
zhuxiaojia2021@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of SE of the Proximal Colon on the AMR

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