Colon PolypsNCT03399045
9 Minutes for Colonoscopy Withdrawal
A study testing 9-minute withdrawal and 6-minute withdrawal in people with Colon Polyps and Colorectal Adenomas, run by Changhai Hospital at 1 site in China.
Trial summary
A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Colon Polyps, Colorectal Adenomas
- What is being tested?
- 9-minute withdrawal and 6-minute withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,027 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2018to 6 Jul 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age is between 40-85.
- Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- Patients who have signed inform consent form
Who cannot join
- Patients who have undergone colonic resection
- Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- Patients with severe chronic cardiopulmonary and renal disease.
- Patients who are unwilling or unable to consent.
- Patients who are not suitable for colonoscopy
- Patients who received urgent or therapeutic colonoscopy
Show all 9Show fewer
- Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
- Patients who are taking aspirin, clopidogrel or other anticoagulants
- Patients with Aronchick score > 3
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 Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial
A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in colonoscopy.
- Conditions
- Colon Polyps, Colorectal Adenomas
- Being tested
- 9-minute withdrawal, 6-minute withdrawal
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-minute withdrawalProcedure or surgery
Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw
6-minute withdrawalProcedure or surgery
Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw
| Study group | Role | What they receive |
|---|---|---|
| 9-minute withdrawal group | Experimental | Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included in the 9 minutes. Receives: Procedure: 9-minute withdrawal |
| 6-minute withdrawal group | Active comparator | Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy willwill not be included in the 9 minutes. Receives: Procedure: 6-minute withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate(ADR)
ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
Measured: 30mins
Secondary outcomes (1)
adenomas per colonoscopy(APC)
APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.
Measured: 30mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start20 Jan 2018
- Primary completion1 Jul 2019
- Study completion6 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon PolypsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, The Second Clinical Medical College of Jinan University, Qinghai People's Hospital, Shaanxi Provincial People's Hospital, Shanghai 8th People's Hospital, Yantaishan Hospital of Yantai City, First Affiliated Hospital of Harbin Medical University, Changzhi People's Hospital, Ningbo Medical Center Lihuili Hospital, The Third People's Hospital of Datong, The First Affiliated Hospital of Shihezi University, The First Affiliated Hospital of Dalian Medical University, Seventh Medical Center of PLA Army General Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Li Zhaoshen, M.D, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399045
- Sponsor's protocol ID
- withdrawal time-1
- Status last verified
- Dec 2019
- First submitted
- 8 Jan 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 33220526
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03399045
- Acronym / sponsor ID
- withdrawal time-1
- Conditions
- Colon Polyps, Colorectal Adenomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, The Second Clinical Medical College of Jinan University, Qinghai People's Hospital, Shaanxi Provincial People's Hospital, Shanghai 8th People's Hospital, Yantaishan Hospital of Yantai City, First Affiliated Hospital of Harbin Medical University, Changzhi People's Hospital, Ningbo Medical Center Lihuili Hospital, The Third People's Hospital of Datong, The First Affiliated Hospital of Shihezi University, The First Affiliated Hospital of Dalian Medical University, Seventh Medical Center of PLA Army General Hospital
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 16 Jan 2018 (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 withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9-minute withdrawal group | Experimental | Procedure: 9-minute withdrawalPatients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included in the 9 minutes. |
| 6-minute withdrawal group | Active comparator | Procedure: 6-minute withdrawalPatients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy willwill not be included in the 9 minutes. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose age is between 40-85.
- Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- Patients who have signed inform consent form
Key exclusion criteria (9 listed)
- Patients who have undergone colonic resection
- Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- Patients with severe chronic cardiopulmonary and renal disease.
- Patients who are unwilling or unable to consent.
- Patients who are not suitable for colonoscopy
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 |
|---|---|---|
| 9-minute withdrawalPatients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw | Procedure or surgery | 9-minute withdrawal group |
| 6-minute withdrawalPatients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw | Procedure or surgery | 6-minute withdrawal group |
Primary outcome
adenoma detection rate(ADR)
Time frame: 30mins
ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
1 secondary outcome
adenomas per colonoscopy(APC)
Time frame: 30mins
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 2 Jan 2020.
- Derived from this study: 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.
- Individual participant dataSharing planned: Undecided
Related trials for Colon Polyps
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
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
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 Zhaoshen, 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 9-minute withdrawal and 6-minute withdrawal in people with Colon Polyps and Colorectal Adenomas, 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 9 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 2 Jan 2020. 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 detection rate(ADR) (time frame: 30mins). 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 NCT03399045, which also lists 1 linked publication.
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 2 Jan 2020.