Adenoma Detection RateNCT04963010
Impact of SFV of Proximal Colon on ADR
A study testing second forward view in people with Adenoma Detection Rate, run by Zhu Xiaojia at 1 site in China.
Trial summary
To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma Detection Rate
- What is being tested?
- second forward view
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2021to 8 Jun 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy -
Exclusion Criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, Boston Bowel Preparation Score (BBPS) <6 points. ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥Recovery of polyp specimens failed, and no histopathological data. ⑦Patients with coagulation dysfunction.
-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third People's Hospital of Jingdezhen City
Jingdezhen, Jiangxi, 333000
Xiaojia Zhu, zhuxiaojia2021@163.com
About this study
Official title: Impact of Second Forward View Examination of the Proximal Colon on Adenoma Detection Rate
To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon). ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥polyp retrieval failure. ⑦Patients with coagulation dysfunction.
Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform.
Read the detailed description
Background:
Colonoscopy can reduce the incidence and mortality rates of colorectal cancer, and the reduction in distal colon cancer is more pronounced than proximal colon cancer. Compared with CRC found on screening, interphase CRC is more likely to occur in the proximal colon above the splenic flexure. Adenoma detection rate (ADR) is an important quality indicator of colonoscopy. Compared with ADR>20%,the incidence of interphase CRC is 10 times higher for endoscopists with ADR<20%. For every 1% increase in ADR, the risk of interphase CRC can be reduced by 3%, and fatal interphase CRC can be reduced by 5%. It is reported in the literature that the second forward view examination of the right colon (cecum, ascending colon, liver flexure) can significantly improve the right colon ADR, however, there is no report on the impact of second forward view examination of the proximal colon ADR (cecum, ascending colon, liver flexure, and transverse colon).
Objective:
To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria: Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:
①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon). ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥polyp retrieval failure. ⑦Patients with coagulation dysfunction.
Methods:
Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform.
Primary Outcome:
proximal colon adenoma detection rate:proportion of patients with proximal colon adenoma found in all colonoscopy patients Secondary Outcome whole colon adenoma detection rate:proportion of patients with colonic adenoma found in all colonoscopy patients Cecal insertion time: the time elapsed from introducing the colonoscope into the anus until intubation of the cecum.
proximal colon withdrawal time: observation time of proximal colon in the absence of polyp removal total withdrawal time:the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal BBPS:Boston bowel preparation score whole colon polyp detection rate:proportion of patients with colonic polyp found in all colonoscopy patients proximal colon polyp detection rate:proportion of patients with proximal colon polyp found in all colonoscopy
Research design Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform. Patients in the second forward view (SFV) group were inserted into the cecum again , colonoscope withdrawal to the splenic flexure, and the newly discovered polyps in the second forward view were also resection. Patients in the standard withdrawal colonoscopy withdraw the scope from the splenic flexure until exiting the anus,observe, if polyps are found, undergo endoscopic resection.
The assistant is responsible for recording the time.Cecal insertion time refers to the time elapsed from introducing the colonoscope into the anus until intubation of the cecum. Proximal colon withdrawal time refers to the observation time of proximal colon. And the total withdrawal time refers to the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal. Record BBPS, the number, location, size, Paris type and postoperative pathology of polyps.
- Conditions
- Adenoma Detection Rate
- Being tested
- second forward view
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second forward viewDiagnostic test
second forward view examination of the proximal colon
| Study group | Role | What they receive |
|---|---|---|
| standard withdrawal colonoscopy | No intervention | Observation of conventional colonoscopy |
| second forward view | Experimental | second forward view examination of the proximal colon Receives: Diagnostic Test: second forward view |
What is being measured
The primary outcome is the main question the study is designed to answer.
proximal colon adenoma detection rate
proportion of patients with proximal colon adenoma found in all colonoscopy patients
Measured: up to 2 years
Secondary outcomes (7)
whole colon adenoma detection rate
proportion of patients with colonic adenoma found in all colonoscopy patients
Measured: up to 2 years
Cecal insertion time
the time elapsed from introducing the colonoscope into the anus until intubation of the cecum
Measured: up to 2 years
proximal colon withdrawal time
observation time of proximal colon in the absence of polyp removal
Measured: up to 2 years
total withdrawal time
the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal
Measured: up to 2 years
BBPS
Boston bowel preparation score
Measured: up to 2 years
whole colon polyp detection rate
proportion of patients with colonic polyp found in all colonoscopy patients
Measured: up to 2 years
proximal colon polyp detection rate
proportion of patients with proximal colon polyp found in all colonoscopy
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start14 Jun 2021
- Primary completion8 Jun 2022 (estimated)
- Study completion8 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma Detection 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
- 910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Xiaojia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Xiaojia, Third People's Hospital of Jingdezhen City
- Investigators
- Li Yang, Study director, Third People's Hospital of Jingdezhen City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963010
- Sponsor's protocol ID
- ThirdPeoplesHJingdezhenCity
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing data after the research over
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Second Forward View Examination of the Proximal Colon on Adenoma Detection Rate
- ClinicalTrials.gov ID
- NCT04963010
- Acronym / sponsor ID
- ThirdPeoplesHJingdezhenCity
- Conditions
- Adenoma Detection Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Zhu XiaojiaUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 8 Jun 2022 (estimated)
- Study completion
- 8 Jun 2022 (estimated)
- First posted
- 15 Jul 2021 (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.
To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon). ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥polyp retrieval failure. ⑦Patients with coagulation dysfunction.
Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform.
Detailed description
Background:
Colonoscopy can reduce the incidence and mortality rates of colorectal cancer, and the reduction in distal colon cancer is more pronounced than proximal colon cancer. Compared with CRC found on screening, interphase CRC is more likely to occur in the proximal colon above the splenic flexure. Adenoma detection rate (ADR) is an important quality indicator of colonoscopy. Compared with ADR>20%,the incidence of interphase CRC is 10 times higher for endoscopists with ADR<20%. For every 1% increase in ADR, the risk of interphase CRC can be reduced by 3%, and fatal interphase CRC can be reduced by 5%. It is reported in the literature that the second forward view examination of the right colon (cecum, ascending colon, liver flexure) can significantly improve the right colon ADR, however, there is no report on the impact of second forward view examination of the proximal colon ADR (cecum, ascending colon, liver flexure, and transverse colon).
Objective:
To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria: Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:
①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon). ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥polyp retrieval failure. ⑦Patients with coagulation dysfunction.
Methods:
Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform.
Primary Outcome:
proximal colon adenoma detection rate:proportion of patients with proximal colon adenoma found in all colonoscopy patients Secondary Outcome whole colon adenoma detection rate:proportion of patients with colonic adenoma found in all colonoscopy patients Cecal insertion time: the time elapsed from introducing the colonoscope into the anus until intubation of the cecum.
proximal colon withdrawal time: observation time of proximal colon in the absence of polyp removal total withdrawal time:the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal BBPS:Boston bowel preparation score whole colon polyp detection rate:proportion of patients with colonic polyp found in all colonoscopy patients proximal colon polyp detection rate:proportion of patients with proximal colon polyp found in all colonoscopy
Research design Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform. Patients in the second forward view (SFV) group were inserted into the cecum again , colonoscope withdrawal to the splenic flexure, and the newly discovered polyps in the second forward view were also resection. Patients in the standard withdrawal colonoscopy withdraw the scope from the splenic flexure until exiting the anus,observe, if polyps are found, undergo endoscopic resection.
The assistant is responsible for recording the time.Cecal insertion time refers to the time elapsed from introducing the colonoscope into the anus until intubation of the cecum. Proximal colon withdrawal time refers to the observation time of proximal colon. And the total withdrawal time refers to the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal. Record BBPS, the number, location, size, Paris type and postoperative pathology of polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard withdrawal colonoscopy | No intervention | –Observation of conventional colonoscopy |
| second forward view | Experimental | Diagnostic Test: second forward viewsecond forward view examination of the proximal colon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 forward viewsecond forward view examination of the proximal colon | Diagnostic test | second forward view |
Primary outcome
proximal colon adenoma detection rate
Time frame: up to 2 years
proportion of patients with proximal colon adenoma found in all colonoscopy patients
7 secondary outcomes
whole colon adenoma detection rate
Time frame: up to 2 years
Cecal insertion time
Time frame: up to 2 years
proximal colon withdrawal time
Time frame: up to 2 years
total withdrawal time
Time frame: up to 2 years
BBPS
Time frame: up to 2 years
whole colon polyp detection rate
Time frame: up to 2 years
proximal colon polyp detection rate
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: Yes. Sharing data after the research over
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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 City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing second forward view in people with Adenoma Detection Rate, run by Zhu Xiaojia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 colon adenoma detection rate (time frame: up to 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 13 Jun 2022.