Adenoma Miss RateNCT05712304
Impact of SE of the Proximal Colon on the AMR
A study testing second examination of the proximal colon in people with Adenoma Miss Rate, run by Third People's Hospital of Jingdezhen City at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma Miss Rate
- What is being tested?
- second examination of the proximal colon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesChina
- Study dates
- 15 Feb 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive patients aged 40-75years undergoing colonoscopy for screening
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Second People's Hospital of Jingdezhen City
Jingdezhen, Jiangxi, 333000
fangxi cheng, 13879858019
- Recruiting
Third People's Hospital of Jingdezhen City
Jingdezhen, Jiangxi, 333000
Xiaojia Zhu, zhuxiaojia2021@163.com
About this study
Official title: Impact of the Second vs. Conventional Examination of the Proximal Colon on Adenoma Miss Rate, a Prospective Randomized Tandem Trial
.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.
Read the 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.
- Conditions
- Adenoma Miss Rate
- Being tested
- second examination of the proximal colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second examination of the proximal colonDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| conventional examination | No intervention | 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 |
| second examination | Experimental | 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 Receives: Diagnostic Test: second examination of the proximal colon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
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
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Adenoma per colonoscopy (APC) or polyp per colonoscopy (PPC)
the total number of adenomas or polyps divided by the total number of patients
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start15 Feb 2023
- Primary completion15 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma Miss RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third People's Hospital of Jingdezhen City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- li yang, Study director, Third People's Hospital of Jingdezhen,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712304
- Sponsor's protocol ID
- LL202211
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Second vs. Conventional Examination of the Proximal Colon on Adenoma Miss Rate, a Prospective Randomized Tandem Trial
- ClinicalTrials.gov ID
- NCT05712304
- Acronym / sponsor ID
- LL202211
- Conditions
- Adenoma Miss Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Third People's Hospital of Jingdezhen CityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional examination | No intervention | –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 |
| second examination | Experimental | Diagnostic Test: second examination of the proximal colonFor 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients aged 40-75years undergoing colonoscopy for screening
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| second examination of the proximal colonFor 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 | Diagnostic test | second examination |
Primary outcome
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.
5 secondary outcomes
proximal polyp miss rate
Time frame: 2 years
Per-patient proximal AMR or per-patient proximal PMR
Time frame: 2 years
The adenoma detection rate (ADR) or polyp detection rate (PDR)
Time frame: 2 years
Adenoma per colonoscopy (APC) or polyp per colonoscopy (PPC)
Time frame: 2 years
proximal advanced AMR(AAMR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Adenoma Miss Rate
Enrolling by invitation
Artificial Intelligence-assisted Colonoscopy, Tandem Study
Artificial Intelligence (AI), Colonoscopy Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li yang study director
Third People's Hospital of Jingdezhen,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing second examination of the proximal colon in people with Adenoma Miss Rate, run by Third People's Hospital of Jingdezhen City at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaojia zhu (15879497590, zhuxiaojia2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proximal AMR (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.