Thorough Flushing Strategy During Colonoscopy Examination

February 10, 2024 updated by: Zhao Hang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • People without contraindications for colonoscopy

Exclusion Criteria:

  • Patients diagnosed with colon polyps

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
limited
patients adopted limited flushing strategy
thorough
Thorough flushing strategy
Procedure: thorough flushing
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
time of examination
Time Frame: 1week
the time from insertion to exit the anus
1week
time of insertion
Time Frame: 1week
the time from insertion to arriving at cecum
1week
time of withdrawl
Time Frame: 1week
the time from cecum to anus
1week
number of polyps
Time Frame: 1week
the number of polyps found
1week
location of polyps
Time Frame: 1week
the location of polyps found
1week
shape of polyps
Time Frame: 1week
the shape of polyps found, classified into lateral, senssile and pediculated three types
1week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Boston score
Time Frame: 1week
the Boston score of bowel preparation (from 0-9)
1week
volume of water
Time Frame: 1week
volume of water used for flushing
1week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-103-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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