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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscope Passage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conventional colonoscope passage

Use conventional colonoscope passage through the sigmoid colon

Group Type ACTIVE_COMPARATOR

Conventional colonoscope passage

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

left colon water exchange colonoscope passage

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

cap-assisted left colon water exchange colonoscope passage

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional colonoscope passage

Use conventional colonoscope passage through the sigmoid colon

Intervention Type PROCEDURE

left colon water exchange colonoscope passage

Use left colon water exchange colonoscope passage through the sigmoid colon

Intervention Type PROCEDURE

cap-assisted left colon water exchange colonoscope passage

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhijun Bao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Danian Ji, M.D.

Role: STUDY_DIRECTOR

Huadong Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Huadong hospital affiliated to Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Danian Ji, M.D.

Role: CONTACT

+86-18019094606

Zhiyu Dong, M.D.

Role: CONTACT

+86-18817870866

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Danian Ji, M.D.

Role: primary

+86-18019094606

Zhiyu Dong, M.D.

Role: backup

+86-18817870866

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025K235

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.