Colon PolypNCT04797065
9 Minutes for Tandem Colonoscopy Withdrawal
A study testing 6-minute then 9-minute withdrawal and 9-minute then 6-minute withdrawal in people with Colon Polyp and Colorectal Adenoma, run by Changhai Hospital at 1 site in China.
Trial summary
A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Colon Polyp, Colorectal Adenoma
- What is being tested?
- 6-minute then 9-minute withdrawal and 9-minute then 6-minute withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 733 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 5 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age is between 40-75.
- Patients who have indications for screening
- Patients who have signed inform consent form.
Who cannot join
- Patients who have undergone colonic resection or polypectomy
- 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
- 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).
Show all 11Show fewer
- Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- 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
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy
A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.
- Conditions
- Colon Polyp, Colorectal Adenoma
- Being tested
- 6-minute then 9-minute withdrawal, 9-minute then 6-minute withdrawal
- Keywords
- withdrawal time, adenoma miss rate, tandem colonoscopy, adenoma detection rate
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute then 9-minute withdrawalProcedure or surgery
Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 2 minutes then in 3 minutes during each colonic segment.
In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes.
9-minute then 6-minute withdrawalProcedure or surgery
Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 3 minutes then in 2 minutes during each colonic segment.
In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 6-minute then 9-minute withdrawal | Experimental | Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 6 minutes then in 9 minutes during the segmental withdrawal.
At 6-minute withdrawal, the left colon, transverse colon and right colon will take 2 minutes each. Then at 9-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 3 minutes each.
A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included. Receives: Procedure: 6-minute then 9-minute withdrawal |
| 9-minute then 6-minute withdrawal | Active comparator | Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 9 minutes then in 6 minutes during the segmental withdrawal.
At 9-minute withdrawal, the left colon, transverse colon and right colon will take 3 minutes each. Then at 6-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 2 minutes each.
A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included. Receives: Procedure: 9-minute then 6-minute withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma miss rate(AMR)
Adenomas detected in the second-pass examination were defined as missed adenomas; the AMR was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.
Measured: 60 minutes
Secondary outcomes (4)
advanced adenoma miss rate(AAMR)
AAMR is the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.
Measured: 60 minutes
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
adenomas per colonoscopy(APC)
APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.
Measured: 60 minutes
patient-level AMR(pAMR)
the number of participants with adenomas detected only during the second-pass colonoscopy divided by the total number of participants with adenomas detected during the tandem colonoscopy
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 Mar 2021
- Study start1 Mar 2021
- Primary completion5 Nov 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon PolypStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, Yantaishan Hospital of Yantai City, Yantai, China, Seventh Medical Center of PLA Army General Hospital, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Shihezi University, Shanghai 8th People's Hospital, Shanxi Provincial People's Hospital, Qinghai People's Hospital, Leqing People's Hospital, Affiliated Hospital of North Sichuan Medical College, Zhejiang University, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine, The General Hospital of Eastern Theater Command, Heilongjiang Provicial Hospital, The Second Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797065
- Sponsor's protocol ID
- withdrawal time-2
- Status last verified
- Jan 2022
- First submitted
- 10 Mar 2021
- Last updated
- 1 Feb 2022
- 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 30738046Zhao S, Song Y, Wang S, Wang R, Feng Z, Gong A, Yang X, Pan P, Yao D, Zhang J, Zhu Y, Li T, Bi J, Ren X, Tang X, Li Q, Yu D, Zheng J, Song B, Wang P, Chen W, Shang G, Xu Y, Xu P, Lai Y, Xu H, Yang X, Sheng J, Tao Y, Li X, Zhu Y, Zhang X, Shen H, Ma Y, Wang F, Wu L, Wang X, Li Z, Bai Y. Reduced Adenoma Miss Rate With 9-Minute vs 6-Minute Withdrawal Times for Screening Colonoscopy: A Multicenter Randomized Tandem Trial. Am J Gastroenterol. 2023 May 1;118(5):802-811. doi: 10.14309/ajg.0000000000002055. Epub 2022 Oct 11.
PubMed 36219172
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy
- ClinicalTrials.gov ID
- NCT04797065
- Acronym / sponsor ID
- withdrawal time-2
- Conditions
- Colon Polyp, Colorectal Adenoma
- Keywords
- withdrawal time, adenoma miss rate, tandem colonoscopy, adenoma detection rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, Yantaishan Hospital of Yantai City, Yantai, China, Seventh Medical Center of PLA Army General Hospital, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Shihezi University, Shanghai 8th People's Hospital, Shanxi Provincial People's Hospital, Qinghai People's Hospital, Leqing People's Hospital, Affiliated Hospital of North Sichuan Medical College, Zhejiang University, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine, The General Hospital of Eastern Theater Command, Heilongjiang Provicial Hospital, The Second Hospital of Hebei Medical University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 15 Mar 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.
A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-minute then 9-minute withdrawal | Experimental | Procedure: 6-minute then 9-minute withdrawalPatients in 6-minute then 9-minute withdrawal group will first be carefully observed in 6 minutes then in 9 minutes during the segmental withdrawal. At 6-minute withdrawal, the left colon, transverse colon and right colon will take 2 minutes each. Then at 9-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 3 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included. |
| 9-minute then 6-minute withdrawal | Active comparator | Procedure: 9-minute then 6-minute withdrawalPatients in 9-minute then 6-minute withdrawal group will first be carefully observed in 9 minutes then in 6 minutes during the segmental withdrawal. At 9-minute withdrawal, the left colon, transverse colon and right colon will take 3 minutes each. Then at 6-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 2 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose age is between 40-75.
- Patients who have indications for screening
- Patients who have signed inform consent form.
Key exclusion criteria (11 listed)
- Patients who have undergone colonic resection or polypectomy
- 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
- Patients with inflammatory bowel diseases
- Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
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 |
|---|---|---|
| 6-minute then 9-minute withdrawalPatients in 6-minute then 9-minute withdrawal group will first be carefully observed in 2 minutes then in 3 minutes during each colonic segment. In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes. | Procedure or surgery | 6-minute then 9-minute withdrawal |
| 9-minute then 6-minute withdrawalPatients in 9-minute then 6-minute withdrawal group will first be carefully observed in 3 minutes then in 2 minutes during each colonic segment. In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes. | Procedure or surgery | 9-minute then 6-minute withdrawal |
Primary outcome
adenoma miss rate(AMR)
Time frame: 60 minutes
Adenomas detected in the second-pass examination were defined as missed adenomas; the AMR was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.
4 secondary outcomes
advanced adenoma miss rate(AAMR)
Time frame: 60 minutes
adenoma detection rate(ADR)
Time frame: 60 minutes
adenomas per colonoscopy(APC)
Time frame: 60 minutes
patient-level AMR(pAMR)
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- 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.
- Derived from this study: PubMed 36219172Zhao S, Song Y, Wang S, Wang R, Feng Z, Gong A, Yang X, Pan P, Yao D, Zhang J, Zhu Y, Li T, Bi J, Ren X, Tang X, Li Q, Yu D, Zheng J, Song B, Wang P, Chen W, Shang G, Xu Y, Xu P, Lai Y, Xu H, Yang X, Sheng J, Tao Y, Li X, Zhu Y, Zhang X, Shen H, Ma Y, Wang F, Wu L, Wang X, Li Z, Bai Y. Reduced Adenoma Miss Rate With 9-Minute vs 6-Minute Withdrawal Times for Screening Colonoscopy: A Multicenter Randomized Tandem Trial. Am J Gastroenterol. 2023 May 1;118(5):802-811. doi: 10.14309/ajg.0000000000002055. Epub 2022 Oct 11.
Related trials for Colon Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
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, M.D 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 6-minute then 9-minute withdrawal and 9-minute then 6-minute withdrawal in people with Colon Polyp and Colorectal 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 11 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: finished, as of the sponsor's last update on 1 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma miss rate(AMR) (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 NCT04797065, which also lists 3 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 1 Feb 2022.