Colorectal Cancer
Conditions
Keywords
full-spectrum endoscopy, polyp detection rate, colorectal cancer, colorectal screening, adenoma detection rate, endoscopic innovations
Brief summary
The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.
Detailed description
Colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in West countries. Colonoscopy is the gold standard for prevention of colorectal cancer disease. Screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. Colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. Although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. Advanced Technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. Full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population. The investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. One arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (EndoChoice) (330º angle view)
Interventions
PROCEDUREcolonoscopy procedure
endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy
Sponsors
Hospital del Rio Hortega
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* patient referred for colorectal cancer screening with positive fecal inmunological test. * Age between 50 and 69 years
Exclusion criteria
* history of colonic resection, * high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome, * inflammatory bowel disease, * patients with lower gastrointestinal bleeding symptoms, * acute diverticulitis, * colonic strictures, * poor bowel preparation (Boston scale less than 5 points)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adenoma detection rate in the two different colonoscopies | one week | number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total procedure time in each group | one week | time since the begining of the procedure till is totally finish |
| Adverse events | one week | Any inmediatly complication |
| advance adenoma rate in each group | one week | 10mm or greater in size, villous component or high grade dysplasia |
| time to caecal intubation in each group | one week | time to reach appendicular orifice |
| polyp retrieval rate in each group | one week | proportion of resected polyps that were retrieved and sent for histologically analysis |
| caecal intubation rate in each group | one week | proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached |
| colonoscopy withdrawal time | one week | average time taken withdraw the colonoscope from the caecal pole to the anus. |
| polyp detection rate in right and left colon in each group | one week | — |
Outcome results
None listed