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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Adenoma

• Registration Number: NCT07097350
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Study Start: 2025-08-01
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 524

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
adenoma detection rate	2 weeks after the procedure

Secondary Outcome Measures

Name	Time	Method
sessile serrated lesion detection rate	2 weeks after the procedure
advanced adenoma detection rate	2 weeks after the procedure
polyp detection rate	2 weeks after the procedure
Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）rate	immediately after the procedure	CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis
Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）rate	2 weeks after the procedure	CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
perforation rate	immediately after the procedure

Trial Locations

Locations (1)

Huadong hospital, Fudan university; 🇨🇳 Shanghai, Shanghai, China