Colon AdenomaNCT05651893
Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy
A study testing re-examination and extended withdraw time in people with Colon Adenoma, run by Changhai Hospital at 1 site in China.
Trial summary
The incidence of colorectal cancer in China is increasing year by year. Studies have shown that colorectal cancer is more common in the left colon，especially in the China. Our previous study also showed a higher rate of missed adenoma in the left colon than the right colon during colonoscopy. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Colon Adenoma
- What is being tested?
- re-examination and extended withdraw time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,516 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Jul 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age are between 40-75, or aged 76-85 depending on his condition
- Patients who have indications for screening
- Patients who have signed inform consent form.
Who cannot join
- Patients who have undergone colonic resection
- Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- Patients with inflammatory bowel diseases
- Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
- Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
Show all 10Show fewer
- Patients with failed cecal intubation
- Patients with poor BPQ that necessitated a second bowel preparation
- Patients with therapeutic colonoscopy for existing lesions
- Patients refusing to participate or to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, 200433
Yu Bai, MD, 86-021-81873241, baiyu1998@hotmail.com
zhaoshen Li, MD
About this study
Official title: Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy: a Multicenter, Prospective, Randomized Controlled Trial
The incidence of colorectal cancer in China is increasing year by year. Studies have shown that colorectal cancer is more common in the left colon，especially in the China. Our previous study also showed a higher rate of missed adenoma in the left colon than the right colon during colonoscopy. Additionally, prolonging withdrawal time could only improve the ADR of right colon, but had limited effect on the ADR of left colon in our previous research. Our aim is to evaluate the effect of a second forward view examination of the left colon on the detection of adenoma detection during colonoscopy.
- Conditions
- Colon Adenoma
- Being tested
- re-examination, extended withdraw time
- Keywords
- Adenoma detection rate, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
re-examinationBehavioural
During colonoscopy, the left colon was examined a second time in the forward view.
extended withdraw timeBehavioural
During colonoscopy, the left colon was examined with double basic withdrawal time in the forward view.
| Study group | Role | What they receive |
|---|---|---|
| Second forward view examination group | Experimental | After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. Then the left colon, including the splenic curvature to the anus, is examined twice in the forward view. Receives: Behavioral: re-examination |
| Extended withdrawal time group | Experimental | After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. The colonoscope was withdrawn to the anus directly with withdrawal time extended to the double routine withdrawal time of the left colon. Receives: Behavioral: extended withdraw time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left colon adenoma detection rate (LCADR)
LCADR is the number of patients with at least one adenoma in the left colon, divided by the total number of patients.
Measured: 60 minutes
Secondary outcomes (2)
adenoma detection rate(ADR)
ADR is the number of patients with at least one adenoma, divided by the total number of patients.
Measured: 60 minutes
left colon adenomas per colonoscopy (LCAPC)
LCAPC was calculated as the number of adenomas detected during in left colon colonoscopy withdraw divided by the number of colonoscopies.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Jan 2023
- Primary completionJan 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, Shanxi Provincial People's Hospital, The General Hospital of Eastern Theater Command, The Sixth Affiliated Hospital of Guangzhou Medical University, Fudan University, Kunshan Hospital of Traditional Chinese Medicine, Ningjin County Hospital, Qinghai People's Hospital, The First Affiliated Hospital of Yangtze University, Qujing NO.1 Hospital, Jiangxi Provincial People's Hopital, Yueyang Central Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The First People's Hospital of Changde City, Xuzhou Central Hospital, Wenzhou Central Hospital, Anhui Provincial Hospital, Jiangsu Provincial People's Hospital, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651893
- Sponsor's protocol ID
- SFW2022-01
- Status last verified
- Apr 2023
- First submitted
- 7 Dec 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao S, Yang X, Wang S, Meng Q, Wang R, Bo L, Chang X, Pan P, Xia T, Yang F, Yao J, Zheng J, Sheng J, Zhao X, Tang S, Wang Y, Wang Y, Gong A, Chen W, Shen J, Zhu X, Wang S, Yan C, Yang Y, Zhu Y, Ma RJ, Wang R, Ma Y, Li Z, Bai Y. Impact of 9-Minute Withdrawal Time on the Adenoma Detection Rate: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e168-e181. doi: 10.1016/j.cgh.2020.11.019. Epub 2020 Nov 19.
PubMed 33220526Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
PubMed 30738046
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy: a Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05651893
- Acronym / sponsor ID
- SFW2022-01
- Conditions
- Colon Adenoma
- Keywords
- Adenoma detection rate, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,516 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, Shanxi Provincial People's Hospital, The General Hospital of Eastern Theater Command, The Sixth Affiliated Hospital of Guangzhou Medical University, Fudan University, Kunshan Hospital of Traditional Chinese Medicine, Ningjin County Hospital, Qinghai People's Hospital, The First Affiliated Hospital of Yangtze University, Qujing NO.1 Hospital, Jiangxi Provincial People's Hopital, Yueyang Central Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The First People's Hospital of Changde City, Xuzhou Central Hospital, Wenzhou Central Hospital, Anhui Provincial Hospital, Jiangsu Provincial People's Hospital, Xiangya Hospital of Central South University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Dec 2022 (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.
The incidence of colorectal cancer in China is increasing year by year. Studies have shown that colorectal cancer is more common in the left colon，especially in the China. Our previous study also showed a higher rate of missed adenoma in the left colon than the right colon during colonoscopy. Additionally, prolonging withdrawal time could only improve the ADR of right colon, but had limited effect on the ADR of left colon in our previous research. Our aim is to evaluate the effect of a second forward view examination of the left colon on the detection of adenoma detection during colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second forward view examination group | Experimental | Behavioral: re-examinationAfter successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. Then the left colon, including the splenic curvature to the anus, is examined twice in the forward view. |
| Extended withdrawal time group | Experimental | Behavioral: extended withdraw timeAfter successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. The colonoscope was withdrawn to the anus directly with withdrawal time extended to the double routine withdrawal time of the left colon. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose age are between 40-75, or aged 76-85 depending on his condition
- Patients who have indications for screening
- Patients who have signed inform consent form.
Key exclusion criteria (10 listed)
- Patients who have undergone colonic resection
- Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- Patients with inflammatory bowel diseases
- Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
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 |
|---|---|---|
| re-examinationDuring colonoscopy, the left colon was examined a second time in the forward view. | Behavioural | Second forward view examination group |
| extended withdraw timeDuring colonoscopy, the left colon was examined with double basic withdrawal time in the forward view. | Behavioural | Extended withdrawal time group |
Primary outcome
Left colon adenoma detection rate (LCADR)
Time frame: 60 minutes
LCADR is the number of patients with at least one adenoma in the left colon, divided by the total number of patients.
2 secondary outcomes
adenoma detection rate(ADR)
Time frame: 60 minutes
left colon adenomas per colonoscopy (LCAPC)
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 33220526Zhao S, Yang X, Wang S, Meng Q, Wang R, Bo L, Chang X, Pan P, Xia T, Yang F, Yao J, Zheng J, Sheng J, Zhao X, Tang S, Wang Y, Wang Y, Gong A, Chen W, Shen J, Zhu X, Wang S, Yan C, Yang Y, Zhu Y, Ma RJ, Wang R, Ma Y, Li Z, Bai Y. Impact of 9-Minute Withdrawal Time on the Adenoma Detection Rate: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e168-e181. doi: 10.1016/j.cgh.2020.11.019. Epub 2020 Nov 19.
- Background: PubMed 30738046Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
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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.
Zhaoshen Li, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing re-examination and extended withdraw time in people with Colon Adenoma, run by Changhai Hospital 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?
The sponsor lists 3 inclusion and 10 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 6 Apr 2023. 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 Zhaoshen Li, MD (86-021-31161365, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left colon adenoma detection rate (LCADR) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05651893, which also lists 2 linked publications.
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 6 Apr 2023.