Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesions is detected, it is recommended to perform endoscopic surveillance with different intervals between explorations. Although the reduction in CRC incidence, endoscopic surveillance is producing a considerable increase in the number of colonoscopies. However, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non inferior alternative to endoscopic surveillance.
Based on this hypothesis, the research group have designed a randomized clinical trial within the population CRC screening programs to compare FIT surveillance to endoscopic surveillance in patients with advanced lesions resected.
Individuals aged 50 to 65 years.
Individuals with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program.
Personal history of CRC.
Colonic lesion ≥10mm resected without histological diagnosis.
More than 10 adenomas in baseline colonoscopy.
Serrated polyposis syndrome.
Parallel
Annual FIT
Diagnostic testPatients will be offered an annual FIT and colonoscopy will be performed if fecal hemoglobin concentration is ≥10µg / g of feces. After performing a colonoscopy the FIT will be sent to the patient: * After one year if the unscheduled colonoscopy has been incomplete or a lesion requiring endoscopic surveillance has been completely resected. * After five years if the colonoscopy has evaluated the entire mucosa, it is normal or with lesions that do not require endoscopic surveillance (1-2 non-advanced adenomas).
Endoscopic surveillance.
Procedure/SurgeryFirst surveillance colonoscopy will be performed in three-year time. If an advanced adenoma or at least three non-advanced adenomas are detected, colonoscopy will be repeated after 3 years. In contrast, if colonoscopy is normal or 1-2 non-advanced adenomas are detected, colonoscopy will be repeated after 5 years.
Rate of invasive CRC
It is the main outcome of the study. Invasive CRC is defined as colonic adenocarcinoma that invades the submucosa. Adenocarcinomas in situ and intramucosal carcinomas will not be considered as invasive CRC.
Rate of interval CRC
Interval CRC is defined as the CRC detected between two organized surveillance (FIT or colonoscopy).
Mortality
The deaths and their cause will be collected: associated with CRC, associated with adverse effects of screening or unrelated.
Rate of advanced colonic lesions
Advanced colonic lesions will be defined as advanced adenomas (at least 10mm, hairy histology or high grade dysplasia) or advanced serrated lesions (at least 10mm or with dysplasia).
CRC, adenoma and advanced serrated lesions at three years
Detection of CRC, adenoma and advanced serrated lesion will be collected at 3 years of follow-up.
Physical activity
We will use the International Physical Activity. Questionnaire (IPAQ) to mesure physical activity.
Mediterranean lifestyle
We will use the Mediterranean Lifestyle index (MEDLIFE) to measure overall adherence to the Mediterranean lifestyle.
Preferences of the subjects
We will use a survey with vignette questions to evaluate the values and preferences of the subjects regarding surveillance.
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