A prospective multicenter randomized controlled trial to evaluate the efficacy of Texture and Color Enhancement Imaging (TXI) observation in the detection of colorectal lesions
- Conditions
- colorectal lesions
- Registration Number
- JPRN-jRCT1032230089
- Lead Sponsor
- Saito Yutaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 960
Patients who meet all of the inclusion criteria 1 to 3 below
1)Patients aged between 40 and 80 at the time of informed consent
2)Patients scheduled for colonoscopy for any of the following:
1.Screening
2.Surveillance after endoscopic treatment (removal of all adenomas)
3.Examination for positive fecal occcult blood test
4.Examination of abdominal symptoms (melena, bloody stool, other symptoms)
3)Patients who have given written informed consent to participate in the study
Patients who do not correspond to any of the following1to7
1)Patients with a history of colorectal surgery (excluding appendectomy)
2)Patients with colonic polyposis
3)Patients with inflammatory bowel disease
4)Patients with known colorectal polyps
5)Women who are pregnant or breastfeeding
6)Patients participating in an interventional study on endoscopy other than this study
7)Patients who are judged to be inappropriate for this study by the attending physician or the examining physician, including underlying diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean adenoma per procedure
- Secondary Outcome Measures
Name Time Method 1)Adenoma detection rate(ADR)<br>2)Advanced ADR<br>3)Polyp detection rate(PDR)<br>4)Flat polyp detection rate(FDR)<br>5)Depressed lesion detection rate (DDR)<br>6)Average number of polyps found per examination<br>7)Sessile serrated lesion detection rate(SDR)<br>8)Average number of SSLs found per inspection<br>9)MAP/ADR by doctor skill level<br>10)MAP/ADR by gross lesion type<br>11)Adverse event frequency