Study procedures
comorbidity, bleeding, CRC, gastrointestinal tract, hemorrhage, colorectal neoplasia, substance abuse
BLEEDING, INTESTINAL PERFORATION, HEMORRHAGE, INTESTINAL PERFORATION, COMPLICATIONS
Colonoscopies were offered free of charge, including bowel-cleansing agents, and were performed by experienced endoscopists using the standard quality aspects defined by the Asociación Española de Gastroenterología [Polyp size and morphology were recorded using the Paris classification [Participants assigned to the FIT group received an annual automated quantitative FIT kit for 3 consecutive years with instructions for home use. They were notified to deliver it within 14 days after taking the sample. Individuals with ≥10 μg Hb/g feces were invited to undergo colonoscopy. We chose a low cutoff threshold because we wanted to increase the sensitivity of FIT for CRC detection. The individuals who did not deliver the test on time were contacted by telephone to offer them a new test.Demographic data and CRC characteristics were recorded from the index cases. Epidemiological data from the eligible FDR included age, sex, history of colorectal neoplasia, substance abuse, comorbidity, deceased or untraceable relatives, and history of NSAID, aspirin, or anticoagulant treatment. Severe complications that occurred during colonoscopy or in the early termination of the procedure (immediate and delayed post-polypectomy hemorrhage and intestinal perforation) were also recorded. We considered severe post-polypectomy bleeding if prevented the conclusion of the procedure, transfusion or hospitalization was required. Intestinal perforation was defined as evidence of air, luminal contents, or instrumentation outside the gastrointestinal tract. The study data were collected and stored in REDcap, hosted at the Asociación Española de Gastroenterología, a database that guarantees data confidentiality [