The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
NCT ID: NCT06992856
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
531 participants
INTERVENTIONAL
2025-06-01
2026-06-01
Brief Summary
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Detailed Description
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2. Randomize patients into 3 interventional groups based on R script (version 4.4.1), including (1) Group 1: Conventional colonoscope passage, (2) Group 2: left colon water exchange colonoscope passage, (3) Group 3: cap-assisted left colon water exchange colonoscope passage.
3. Collecting variables which consist of primary and secodary outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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conventional colonoscope passage
Use conventional colonoscope passage through the sigmoid colon
Conventional colonoscope passage
Use conventional colonoscope passage through the sigmoid colon
left colon water exchange colonoscope passage
Use left colon water exchange colonoscope passage through the sigmoid colon
left colon water exchange colonoscope passage
Use left colon water exchange colonoscope passage through the sigmoid colon
Cap-assisted left colon water exchange colonoscope passage
Use Cap-assisted left colon water exchange colonoscope passage through the sigmoid colon
cap-assisted left colon water exchange colonoscope passage
Use cap-assisted left colon water exchange colonoscope passage through sigmoid colon
Interventions
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Conventional colonoscope passage
Use conventional colonoscope passage through the sigmoid colon
left colon water exchange colonoscope passage
Use left colon water exchange colonoscope passage through the sigmoid colon
cap-assisted left colon water exchange colonoscope passage
Use cap-assisted left colon water exchange colonoscope passage through sigmoid colon
Eligibility Criteria
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Inclusion Criteria
* sedation colonoscopy
Exclusion Criteria
* Clinical suspicion of, or pathologically confirmed, colorectal cancer
* Presence of any "alarm" symptom or sign-hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination
* Pregnancy or lactation
* Known or suspected gastrointestinal obstruction
* Diagnosed inflammatory bowel disease
* Use of antiplatelet or anticoagulant therapy (e.g., aspirin, warfarin) within 7 days before colonoscopy or any documented coagulation disorder
* Current enrolment in another clinical study or participation in any clinical trial within the previous 60 days
* Requirement for emergency colonoscopy
* Any other condition that, in the investigators' judgment, renders the patient unsuitable for inclusion in the study
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhijun Bao
Director
Principal Investigators
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Danian Ji, M.D.
Role: STUDY_DIRECTOR
Huadong Hospital
Locations
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Huadong hospital affiliated to Fudan university
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025K235
Identifier Type: -
Identifier Source: org_study_id
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