Colorectal Adenoma
Conditions
Keywords
transparent cap, computer-aided detection, adenoma detection rate
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.
Interventions
DEVICEcomputer-aided detection alone
colonoscopy with computer-aided detection
DEVICEtransparent cap-assisted colonoscopy combined with computer-aided detection
transparent cap-assisted colonoscopy combined with computer-aided detection
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adenoma detection rate | 2 weeks after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| advanced adenoma detection rate | 2 weeks after the procedure | — |
| polyp detection rate | 2 weeks after the procedure | — |
| sessile serrated lesion detection rate | 2 weeks after the procedure | — |
| 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 | — |
| 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 |
Countries
China
Contacts
Primary ContactDanian Ji, M.D.
Backup ContactZhiyu Dong, M.D.
Outcome results
None listed