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CompletedNCT06117553Updated Feb 13, 2024

Thorough Flushing Strategy During Colonoscopy Examination

An observational study in Colonoscopy, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Colonoscopy

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Keywords

  • colonoscopy, quality, polyps
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

Inclusion criteria

  • People without contraindications for colonoscopy

Exclusion criteria

Exclusion Criteria:

  • Patients diagnosed with colon polyps
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • limited

    patients adopted limited flushing strategy

  • thorough

    Thorough flushing strategy

    Procedure: thorough flushing

Interventions

  • Procedurethorough 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

05

What researchers measure

Primary outcomes

  1. time of examination

    the time from insertion to exit the anus

    Time frame: 1week

  2. time of insertion

    the time from insertion to arriving at cecum

    Time frame: 1week

  3. time of withdrawl

    the time from cecum to anus

    Time frame: 1week

  4. number of polyps

    the number of polyps found

    Time frame: 1week

  5. location of polyps

    the location of polyps found

    Time frame: 1week

  6. shape of polyps

    the shape of polyps found, classified into lateral, senssile and pediculated three types

    Time frame: 1week

Secondary outcomes

  1. Boston score

    the Boston score of bowel preparation (from 0-9)

    Time frame: 1week

  2. volume of water

    volume of water used for flushing

    Time frame: 1week

06

Study locations

1 site
  • Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
    Shanghai, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06117553
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai University of Traditional Chinese Medicine
Responsible party
Zhao Hang (Head of Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Nov 7, 2023
Start date
Aug 1, 2023
Primary completion
Dec 31, 2023
Completion
Jan 31, 2024
Last update
Feb 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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