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Study Protocol

Polyprev: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test with Endoscopic Surveillance after Advanced Adenoma Resection in Colorectal Cancer Screening Programs: A Study Protocol

1
Department of Gastroenterology, Instituto de Investigación Sanitaria Galicia Sur, Hospital Universitario de Ourense, 32005 Ourense, Spain
2
Conselleria de Sanidade, Dirección Xeral de Saúde Pública, 15704 Galicia, Spain
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Osakidetza Basque Health Service, Basque Country Colorectal Cancer Screening Programme, 48009 Bilbao, Spain
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Biocruces Health Research Institute, Cancer Biomarker Area, 48903 Barakaldo, Spain
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Servicio de Promoción de la Salud y Prevención en el Entorno Sanitario, Dirección General de Salud Pública y Adicciones, 46021 Valencia, Spain
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Colon and Rectal Cancer Prevention Program, Directorate General for Public Health, Autonomous Government for Health, 30008 Mucia, Spain
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Department of Gastroenterology, Hospital Clínico Universitario Virgen de la Arrixaca, 30120 Murcia, Spain
*
Author to whom correspondence should be addressed.
Academic Editor: Takuji Tanaka
Diagnostics 2021, 11(9), 1520; https://doi.org/10.3390/diagnostics11091520
Received: 5 August 2021 / Revised: 13 August 2021 / Accepted: 17 August 2021 / Published: 24 August 2021
(This article belongs to the Special Issue Fecal Immunochemical Test: Colorectal Cancer Screening and Beyond)
Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesion is detected, clinical practice guidelines recommend endoscopic surveillance with different intervals between explorations. Endoscopic surveillance is producing a considerable increase in the number of colonoscopies, with a limited effect on the CRC incidence. Instead, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non-inferior alternative to endoscopic surveillance to reduce 10-year CRC incidence. Based on this hypothesis, we have designed a multicenter and randomized clinical trial within the Spanish population CRC screening programs to compare FIT surveillance with endoscopic surveillance. We will include individuals aged from 50 to 65 years with complete colonoscopy and advanced lesions resected within the CRC screening programs. Patients will be randomly allocated to perform an annual FIT and colonoscopy if fecal hemoglobin concentration is ≥10 µg/g, or to perform endoscopic surveillance. On the basis of the non-superior CRC incidence, we will recruit 1894 patients in each arm. The main endpoint is 10-year CRC incidence and the secondary endpoints are diagnostic yield, participation, adverse effects, mortality and cost-effectiveness. Our results may modify the clinical practice after advanced colonic resection in CRC screening programs. View Full-Text
Keywords: colorectal cancer; screening programs; fecal immunochemical test; endoscopic surveillance colorectal cancer; screening programs; fecal immunochemical test; endoscopic surveillance
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MDPI and ACS Style

Regueiro, C.; Almazán, R.; Portillo, I.; Besó, M.; Tourne-Garcia, C.; Rodríguez-Camacho, E.; Ono, A.; Gómez-Amorín, Á.; Cubiella, J. Polyprev: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test with Endoscopic Surveillance after Advanced Adenoma Resection in Colorectal Cancer Screening Programs: A Study Protocol. Diagnostics 2021, 11, 1520. https://doi.org/10.3390/diagnostics11091520

AMA Style

Regueiro C, Almazán R, Portillo I, Besó M, Tourne-Garcia C, Rodríguez-Camacho E, Ono A, Gómez-Amorín Á, Cubiella J. Polyprev: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test with Endoscopic Surveillance after Advanced Adenoma Resection in Colorectal Cancer Screening Programs: A Study Protocol. Diagnostics. 2021; 11(9):1520. https://doi.org/10.3390/diagnostics11091520

Chicago/Turabian Style

Regueiro, Cristina, Raquel Almazán, Isabel Portillo, María Besó, Carlos Tourne-Garcia, Elena Rodríguez-Camacho, Akiko Ono, Ángel Gómez-Amorín, and Joaquín Cubiella. 2021. "Polyprev: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test with Endoscopic Surveillance after Advanced Adenoma Resection in Colorectal Cancer Screening Programs: A Study Protocol" Diagnostics 11, no. 9: 1520. https://doi.org/10.3390/diagnostics11091520

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