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Trial Title:
Impact of SE of the Proximal Colon on the AMR
NCT ID:
NCT05712304
Condition:
Adenoma Miss Rate
Conditions: Official terms:
Adenoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
second examination of the proximal colon
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
Arm group label:
second examination
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.
Criteria for 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.
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Second People's Hospital of Jingdezhen City
Address:
City:
Jingdezhen
Zip:
333000
Country:
China
Status:
Recruiting
Contact:
Last name:
fangxi cheng
Phone:
13879858019
Facility:
Name:
Third People's Hospital of Jingdezhen City
Address:
City:
Jingdezhen
Zip:
333000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojia Zhu
Email:
zhuxiaojia2021@163.com
Start date:
February 15, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Third People's Hospital of Jingdezhen City
Agency class:
Other
Source:
Third People's Hospital of Jingdezhen City
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05712304
