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

Fudan University

Status: Not yet enrolling

Conditions: Colonoscope Passage

Treatments: Procedure: left colon water exchange colonoscope passage; Procedure: cap-assisted left colon water exchange colonoscope passage; Procedure: Conventional colonoscope passage

Study type: Interventional

Funder types: Other

Identifiers

NCT06992856

2025K235

Details and patient eligibility

About

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

Full 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.

Enrollment: 531 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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531 participants in 3 patient groups

conventional colonoscope passage

Active Comparator group

Description:

Use conventional colonoscope passage through the sigmoid colon

Treatment:

Procedure: Conventional colonoscope passage

left colon water exchange colonoscope passage

Experimental group

Description:

Use left colon water exchange colonoscope passage through the sigmoid colon

Treatment:

Procedure: left colon water exchange colonoscope passage

Cap-assisted left colon water exchange colonoscope passage

Experimental group

Description:

Use Cap-assisted left colon water exchange colonoscope passage through the sigmoid colon

Treatment:

Procedure: cap-assisted left colon water exchange colonoscope passage