Clinical trial NCT06992856: The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
Official title: The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonoscope Passage
Keywords: colonoscope passage
left colon water exchange
cap-assisted
without loop formation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The proportion of straight passage through the sigmoid colon without loop formation
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Cecal intubation rate
timeFrame: immediately after the procedure
measure: Cecal intubation time
timeFrame: immediately after the procedure
measure: Time of insertion to cecum
timeFrame: immediately after the procedure
measure: Colonoscope insertion failure rate
timeFrame: immediately after the procedure
measure: Adenoma detection rate
timeFrame: 2 weeks after the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong hospital affiliated to Fudan university
state: Shanghai
Study officials:
affiliation: Huadong Hospital
name: Danian Ji, M.D.
role: STUDY_DIRECTOR
References: