NCT06117553

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

October 26, 2023

Last Update Submit

February 10, 2024

Conditions

Keywords

colonoscopy, quality, polyps

Outcome Measures

Primary Outcomes (6)

  • time of examination

    the time from insertion to exit the anus

    1week

  • time of insertion

    the time from insertion to arriving at cecum

    1week

  • time of withdrawl

    the time from cecum to anus

    1week

  • number of polyps

    the number of polyps found

    1week

  • location of polyps

    the location of polyps found

    1week

  • shape of polyps

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

    1week

Secondary Outcomes (2)

  • Boston score

    1week

  • volume of water

    1week

Study Arms (2)

limited

patients adopted limited flushing strategy

thorough

Thorough flushing strategy

Procedure: thorough flushing

Interventions

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

thorough

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • People without contraindications for colonoscopy

You may not qualify if:

  • Patients diagnosed with colon polyps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, China

Location

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Gastroenterology

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 7, 2023

Study Start

August 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations