ColonoscopyNCT06117553
Thorough Flushing Strategy During Colonoscopy Examination
An observational study of Colonoscopy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen. Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- thorough flushing
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Jan 2024
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 160 patients were selected for colonoscopy examination and randomly assigned to the study group and control group. The two groups used a thorough flushing strategy and a limited flushing strategy to complete colonoscopy examination. The research group adopted a thorough flushing strategy, while the control group adopted a limited flushing strategy. The thorough flushing strategy refers to the thorough flushing of all liquid and foam accumulation areas during the inspection. Make all the liquid accumulation parts in the intestinal cavity free of aspiratable liquid retention. The limited flushing strategy refers to not pursuing full liquid suction, but flushing until it is clear enough for observation. The limited flushing strategy is currently the conventional flushing method for colonoscopy.
Who may be able to join
- People without contraindications for colonoscopy
Who cannot join
- Patients diagnosed with colon polyps
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai
About this study
Official title: Clinical Study on the Application of Thorough Flushing Strategy During Colonoscopy Examination
The investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen. Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy. The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups. Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.
Read the detailed description
Most physicians do not adopt a strategy of complete suction of fluid from the intestinal lumen during colonoscopy. There are both concerns about the time required for colonoscopy and the possibility of inability to thorough cleannig up. Some endoscopists believe that the visual field for partial cleaning of fecal water is acceptable and does not affect observation. This study aims to make an observation and comparison based on the existing problems mentioned above. With the help of direct water injection system, the investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen. Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy. The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups. Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.
- Conditions
- Colonoscopy
- Being tested
- thorough flushing
- Keywords
- colonoscopy, quality, polyps
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thorough flushingProcedure or surgery
The thorough flushing strategy refers to the thorough flushing of all liquid and foam accumulation areas during the inspection. Make all liquid accumulation parts in the intestinal cavity free of aspiratable liquid retention
| Study group | Role | What they receive |
|---|---|---|
| limited | patients adopted limited flushing strategy | |
| thorough | Thorough flushing strategy Receives: Procedure: thorough flushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of examination
the time from insertion to exit the anus
Measured: 1week
time of insertion
the time from insertion to arriving at cecum
Measured: 1week
time of withdrawl
the time from cecum to anus
Measured: 1week
number of polyps
the number of polyps found
Measured: 1week
location of polyps
the location of polyps found
Measured: 1week
shape of polyps
the shape of polyps found, classified into lateral, senssile and pediculated three types
Measured: 1week
Secondary outcomes (2)
Boston score
the Boston score of bowel preparation (from 0-9)
Measured: 1week
volume of water
volume of water used for flushing
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Zhao Hang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117553
- Sponsor's protocol ID
- KY-103-01
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2023
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Application of Thorough Flushing Strategy During Colonoscopy Examination
- ClinicalTrials.gov ID
- NCT06117553
- Acronym / sponsor ID
- KY-103-01
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, quality, polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 7 Nov 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.
The investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen. Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy. The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups. Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.
Detailed description
Most physicians do not adopt a strategy of complete suction of fluid from the intestinal lumen during colonoscopy. There are both concerns about the time required for colonoscopy and the possibility of inability to thorough cleannig up. Some endoscopists believe that the visual field for partial cleaning of fecal water is acceptable and does not affect observation. This study aims to make an observation and comparison based on the existing problems mentioned above. With the help of direct water injection system, the investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen. Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy. The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups. Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| limited | – | –patients adopted limited flushing strategy |
| thorough | – | Procedure: thorough flushingThorough flushing strategy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 160 patients were selected for colonoscopy examination and randomly assigned to the study group and control group. The two groups used a thorough flushing strategy and a limited flushing strategy to complete colonoscopy examination. The research group adopted a thorough flushing strategy, while the control group adopted a limited flushing strategy. The thorough flushing strategy refers to the thorough flushing of all liquid and foam accumulation areas during the inspection. Make all the liquid accumulation parts in the intestinal cavity free of aspiratable liquid retention. The limited flushing strategy refers to not pursuing full liquid suction, but flushing until it is clear enough for observation. The limited flushing strategy is currently the conventional flushing method for colonoscopy.
Key inclusion criteria (1 listed)
- People without contraindications for colonoscopy
Key exclusion criteria (1 listed)
- Patients diagnosed with colon polyps
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 |
|---|---|---|
| thorough flushingThe thorough flushing strategy refers to the thorough flushing of all liquid and foam accumulation areas during the inspection. Make all liquid accumulation parts in the intestinal cavity free of aspiratable liquid retention | Procedure or surgery | thorough |
Primary outcome
time of examination
Time frame: 1week
the time from insertion to exit the anus
time of insertion
Time frame: 1week
the time from insertion to arriving at cecum
time of withdrawl
Time frame: 1week
the time from cecum to anus
number of polyps
Time frame: 1week
the number of polyps found
location of polyps
Time frame: 1week
the location of polyps found
shape of polyps
Time frame: 1week
the shape of polyps found, classified into lateral, senssile and pediculated three types
2 secondary outcomes
Boston score
Time frame: 1week
volume of water
Time frame: 1week
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 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 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: finished, as of the sponsor's last update on 13 Feb 2024. 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?
time of examination (time frame: 1week). The study lists 6 primary outcomes in all. 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 Feb 2024.