• N. Engl. J. Med. · Oct 2022

    Randomized Controlled Trial Pragmatic Clinical Trial

    Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death.

    • Michael Bretthauer, Magnus Løberg, Paulina Wieszczy, Mette Kalager, Louise Emilsson, Kjetil Garborg, Maciej Rupinski, Evelien Dekker, Manon Spaander, Marek Bugajski, Øyvind Holme, Ann G Zauber, Nastazja D Pilonis, Andrzej Mroz, Ernst J Kuipers, Joy Shi, Miguel A Hernán, Hans-Olov Adami, Jaroslaw Regula, Geir Hoff, Michal F Kaminski, and NordICC Study Group.
    • From the Clinical Effectiveness Research Group (M. Bretthauer, M.L., P.W., M.K., K.G., M. Bugajski, Ø.H., H.-O.A., M.F.K.) and the Department of General Practice, Institute of Health and Society (L.E.), University of Oslo, the Clinical Effectiveness Research Group, Department of Transplantation Medicine, Oslo University Hospital (M. Bretthauer, M.L., M.K., K.G., Ø.H., H.-O.A.), and the Cancer Registry of Norway (G.H.), Oslo, the Institute of Clinical Medicine, University of Tromsø, Tromsø (M. Bretthauer), and the Department of Research and Development, Telemark Hospital, Skien (G.H.) - all in Norway; the Department of Gastroenterological Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology (P.W., M.R., M. Bugajski, N.D.P., A.M., J.R., M.F.K.), and the Departments of Pathology (A.M.) and Gastroenterological Oncology (P.W., M.R., M. Bugajski, N.D.P., A.M., J.R., M.F.K.), Medical Center of Postgraduate Education - both in Warsaw, Poland; Vårdcentralen Värmlands Nysäter and the Center for Clinical Research, County Council of Värmland, Karlsdad (L.E.), and the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solna (L.E., H.-O.A.) - both in Sweden; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, and the University of Amsterdam, Amsterdam (E.D.), and the Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam (M.S., E.J.K.) - all in the Netherlands; the Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York (A.G.Z.); and CAUSALab, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston (J.S., M.A.H.).
    • N. Engl. J. Med. 2022 Oct 27; 387 (17): 154715561547-1556.

    BackgroundAlthough colonoscopy is widely used as a screening test to detect colorectal cancer, its effect on the risks of colorectal cancer and related death is unclear.MethodsWe performed a pragmatic, randomized trial involving presumptively healthy men and women 55 to 64 years of age drawn from population registries in Poland, Norway, Sweden, and the Netherlands between 2009 and 2014. The participants were randomly assigned in a 1:2 ratio either to receive an invitation to undergo a single screening colonoscopy (the invited group) or to receive no invitation or screening (the usual-care group). The primary end points were the risks of colorectal cancer and related death, and the secondary end point was death from any cause.ResultsFollow-up data were available for 84,585 participants in Poland, Norway, and Sweden - 28,220 in the invited group, 11,843 of whom (42.0%) underwent screening, and 56,365 in the usual-care group. A total of 15 participants had major bleeding after polyp removal. No perforations or screening-related deaths occurred within 30 days after colonoscopy. During a median follow-up of 10 years, 259 cases of colorectal cancer were diagnosed in the invited group as compared with 622 cases in the usual-care group. In intention-to-screen analyses, the risk of colorectal cancer at 10 years was 0.98% in the invited group and 1.20% in the usual-care group, a risk reduction of 18% (risk ratio, 0.82; 95% confidence interval [CI], 0.70 to 0.93). The risk of death from colorectal cancer was 0.28% in the invited group and 0.31% in the usual-care group (risk ratio, 0.90; 95% CI, 0.64 to 1.16). The number needed to invite to undergo screening to prevent one case of colorectal cancer was 455 (95% CI, 270 to 1429). The risk of death from any cause was 11.03% in the invited group and 11.04% in the usual-care group (risk ratio, 0.99; 95% CI, 0.96 to 1.04).ConclusionsIn this randomized trial, the risk of colorectal cancer at 10 years was lower among participants who were invited to undergo screening colonoscopy than among those who were assigned to no screening. (Funded by the Research Council of Norway and others; NordICC ClinicalTrials.gov number, NCT00883792.).Copyright © 2022 Massachusetts Medical Society.

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