Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas

Fudan University

Status: Not yet enrolling

Conditions: Colorectal Adenoma

Treatments: Device: transparent cap-assisted colonoscopy combined with computer-aided detection; Device: computer-aided detection alone

Study type: Interventional

Funder types: Other

Identifiers

NCT07097350

2025K239

Details and patient eligibility

About

A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate

Full description

1. Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
2. Randomize into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: computer-aided detection alone and (2) Group 2: transparent cap-assisted computer-aided detection.
3. Collecting variables which consist of primary and secodary outcomes.

Enrollment: 524 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 45-75 years

Exclusion criteria

• Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, or treatment of histologically confirmed polyps
• Patients with highly suspected or pathologically confirmed colorectal cancer
• Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination)
• Pregnant or breastfeeding women
• Patients with gastrointestinal obstruction
• Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome
• Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders
• Patients currently enrolled in another clinical study or who participated in any clinical trial within the past 60 days
• Insertion failure for any reason (e.g., scope cannot pass an obstruction, patient cannot tolerate the procedure) or colonoscopy not reaching the cecum
• A Boston Bowel Preparation Scale (BBPS) score < 6 at scope insertion (inadequate preparation requiring repeat bowel cleansing)
• Use of non-guideline-recommended bowel preparation agents
• Patients undergoing emergency colonoscopy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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524 participants in 2 patient groups

computer-aided detection alone

Active Comparator group

Description:

colonoscopy with computer-aided detection alone

Treatment:

Device: computer-aided detection alone

transparent cap-assisted colonoscopy combined with computer-aided detection

Experimental group

Description:

transparent cap-assisted colonoscopy combined with computer-aided detection

Treatment:

Device: transparent cap-assisted colonoscopy combined with computer-aided detection