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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06992856
Enrollment
531
Registered
2025-05-28
Start date
2025-06-01
Completion date
2026-06-01
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscope Passage

Keywords

colonoscope passage, left colon water exchange, cap-assisted, without loop formation

Brief summary

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

PROCEDUREConventional colonoscope passage

Use conventional colonoscope passage through the sigmoid colon

PROCEDUREleft colon water exchange colonoscope passage

Use left colon water exchange colonoscope passage through the sigmoid colon

PROCEDUREcap-assisted left colon water exchange colonoscope passage

Use cap-assisted left colon water exchange colonoscope passage through sigmoid colon

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of straight passage through the sigmoid colon without loop formationimmediately after the procedure

Secondary

MeasureTime frame
Cecal intubation rateimmediately after the procedure
Cecal intubation timeimmediately after the procedure
Time of insertion to cecumimmediately after the procedure
Colonoscope insertion failure rateimmediately after the procedure
Adenoma detection rate2 weeks after the procedure

Countries

China

Contacts

Primary ContactDanian Ji, M.D.
arctg4@163.com+86-18019094606
Backup ContactZhiyu Dong, M.D.
18817870866@163.com+86-18817870866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026