- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712304
Impact of SE of the Proximal Colon on the AMR
Impact of the Second vs. Conventional Examination of the Proximal Colon on Adenoma Miss Rate, a Prospective Randomized Tandem Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 After successful insertion in the cecum, the colonoscope was slowly withdrawn to the splenic flexure and the mucosa was carefully observed, the polyps that were found were removed for histopathologic examination(first pass).Once the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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangxi
-
Jingdezhen, Jiangxi, China, 333000
- Recruiting
- Third People's Hospital of Jingdezhen City
-
Contact:
- Xiaojia Zhu
- Email: zhuxiaojia2021@163.com
-
Jingdezhen, Jiangxi, China, 333000
- Recruiting
- Second People's Hospital of Jingdezhen City
-
Contact:
- fangxi cheng
- Phone Number: 13879858019
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: conventional examination
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
|
|
Experimental: second examination
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 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proximal AMR
Time Frame: 2 years
|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proximal polyp miss rate
Time Frame: 2 years
|
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
|
2 years
|
Per-patient proximal AMR or per-patient proximal PMR
Time Frame: 2 years
|
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
|
2 years
|
The adenoma detection rate (ADR) or polyp detection rate (PDR)
Time Frame: 2 years
|
the proportion of patients with at least one adenoma or polyp detected during the tandem colonoscopy
|
2 years
|
Adenoma per colonoscopy (APC) or polyp per colonoscopy (PPC)
Time Frame: 2 years
|
the total number of adenomas or polyps divided by the total number of patients
|
2 years
|
proximal advanced AMR(AAMR)
Time Frame: 2 years
|
Advanced adenoma is defined as an adenoma with a size ≥10 mm, with tubulovillous or villous histology, or with high-grade dysplasia.
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LL202211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenoma Miss Rate
-
Alexandra Hospital, Athens, GreeceCompletedColonoscopy | Adenoma Detection Rate | Adenoma Miss Rate | RetroflexionGreece
-
Evergreen General Hospital, TaiwanCompletedRight Colon Adenoma Miss Rate | Right Colon Hyperplastic Polyp Miss RateTaiwan
-
Evergreen General Hospital, TaiwanTaipei Medical University Hospital; Dalin Tzu Chi General Hospital; Sepulveda...CompletedRight Colon Adenoma Miss Rate | Right Colon Hyperplastic Polyp Miss RateTaiwan
-
E-DA HospitalChung Shan Medical UniversityRecruitingAdenoma Detection RateTaiwan
-
Evergreen General Hospital, TaiwanChang Gung Memorial Hospital; E-DA Hospital; E-Da Dachang Hospital; Sepulveda Ambulatory...RecruitingColonoscopy | Adenoma Detection RateUnited States, Taiwan
-
Hospital Universitario de CanariasNot yet recruitingAdenoma Detection Rate
-
Hospital Universitario de CanariasCompletedAdenoma Detection RateSpain
-
Gastroenterologie Baden-WettingenCompleted
-
Renmin Hospital of Wuhan UniversityUnknownAdenoma Detection RateChina
Clinical Trials on second examination of the proximal colon
-
Yanqing LiCompletedColonic PolypsChina
-
Chinese University of Hong KongCompletedColorectal Cancer | Colonic PolypHong Kong
-
University Hospital, MontpellierCompletedFetal Volvulus | Midgut VolvulusFrance
-
Erasmus Medical CenterNot yet recruitingCerebral Palsy | Hip Dislocation
-
Mansoura UniversityCompletedDental Restoration Failure of Marginal IntegrityEgypt
-
Hôpital Edouard HerriotCompletedCritically Ill PatientsFrance
-
Attikon HospitalCompletedSonographic Detection of Musculocutaneous NerveGreece
-
Rabin Medical CenterUnknown
-
Rabin Medical CenterUnknown
-
University of CopenhagenHvidovre University HospitalRecruitingColorectal Cancer | Lynch Syndrome | Familial Adenomatous Polyposis | Hereditary Non-polyposis Colon CancerDenmark