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Not yet recruiting NCT06992856

The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation

No phase Interventional Colonoscope Passage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional colonoscope passage, left colon water exchange colonoscope passage, cap-assisted left colon water exchange colonoscope passage.
Who it may be relevant to
Registry conditions: Colonoscope Passage. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

A prospective, single-center, single-blind, randomized controlled study to compare the proportion of straight passage through the sigmoid colon without loop formation between conventional colonoscope passage, left colon water exchange colonoscope passage, and cap-assisted left colon water exchange colonoscope passage through the sigmoid colon

Detailed description

1. Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University. 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.

Interventions

  • Procedure Conventional colonoscope passage
    Use conventional colonoscope passage through the sigmoid colon
  • Procedure left colon water exchange colonoscope passage
    Use left colon water exchange colonoscope passage through the sigmoid colon
  • Procedure cap-assisted left colon water exchange colonoscope passage
    Use cap-assisted left colon water exchange colonoscope passage through sigmoid colon

Primary outcome measures

  • The proportion of straight passage through the sigmoid colon without loop formation [Time frame: immediately after the procedure]
Secondary outcome measures (5)
  • Cecal intubation rate [Time frame: immediately after the procedure]
  • Cecal intubation time [Time frame: immediately after the procedure]
  • Time of insertion to cecum [Time frame: immediately after the procedure]
  • Colonoscope insertion failure rate [Time frame: immediately after the procedure]
  • Adenoma detection rate [Time frame: 2 weeks after the procedure]

Eligibility criteria

Inclusion criteria

  • aged 18-80 years
  • sedation colonoscopy

Exclusion criteria

  • History of colorectal surgery
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

China · 1 center
  • Huadong hospital affiliated to Fudan university — Shanghai

Identifiers

NCT: NCT06992856 · 2025K235

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗