Background: Screening for colorectal cancer (CRC) is widely accepted, but there is no consensus on the preferred strategy. We conducted a randomised trial comparing participation and detection rates (DR) per screenee of guaiac-based faecal occult blood test (gFOBT), immunochemical FOBT (FIT), and flexible sigmoidoscopy (FS) for CRC screening.
Methods: A representative sample of the Dutch population (n = 15 011), aged 50–74 years, was 1:1:1 randomised prior to invitation to one of the three screening strategies. Colonoscopy was indicated for screenees with a positive gFOBT or FIT, and for those in whom FS revealed a polyp with a diameter ⩾10 mm; adenoma with ⩾25% villous component or high grade dysplasia; serrated adenoma; ⩾3 adenomas; ⩾20 hyperplastic polyps; or CRC.
Results: The participation rate was 49.5% (95% confidence interval (CI) 48.1 to 50.9%) for gFOBT, 61.5% (CI, 60.1 to 62.9%) for FIT and 32.4% (CI, 31.1 to 33.7%) for FS screening. gFOBT was positive in 2.8%, FIT in 4.8% and FS in 10.2%. The DR of advanced neoplasia was significantly higher in the FIT (2.4%; OR, 2.0; CI, 1.3 to 3.1) and the FS arm (8.0%; OR, 7.0; CI, 4.6 to 10.7) than the gFOBT arm (1.1%). FS demonstrated a higher diagnostic yield of advanced neoplasia per 100 invitees (2.4; CI, 2.0 to 2.8) than gFOBT (0.6; CI, 0.4 to 0.8) or FIT (1.5; CI, 1.2 to 1.9) screening.
Conclusion: This randomised population-based CRC-screening trial demonstrated superior participation and detection rates for FIT compared to gFOBT screening. FIT screening should therefore be strongly preferred over gFOBT screening. FS screening demonstrated a higher diagnostic yield per 100 invitees than both FOBTs.
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Funding This trial was funded by the Dutch Cancer Society (EMCR 2006-3673), the Dutch Ministry of Health, Health Care Prevention Program–Implementation (ZonMw 2006-5877), Olympus Medical Systems Europe GmbH, Hamburg, Germany and Eiken Chemical Co., Tokyo, Japan.
Competing interests None.
Ethics approval The study was approved by the Dutch Ministry of Health (2006/02WBO). The approval included the pre-randomisation design. The study letters and information brochures were approved by the Institutional Review Board of the Erasmus MC (MEC-2005-264).
EJ Kuipers, JDH Habbema and M van Ballegooijen conceived the idea for the study; EJ Kuipers, JDH Habbema, M van Ballegooijen and ME van Leerdam designed the protocol; EJ Kuipers and JDH Habbema supervised the execution of the study; L Hol performed the retrieval of the population sample and the randomisation in collaboration with Tenalea, Amsterdam; JCIY Reijerink was responsible for the retrieval of the target population from the municipal registries and all mailings; AJ van Vuuren was responsible for the analyses of the FOBTs; ME van Leerdam was responsible for the endoscopy programme; H van Dekken evaluated all pathology samples of the sigmoidoscopies. JCIY Reijerink, ME van Leerdam and L Hol were responsible for the database design; L Hol was responsible for data entry; ACM van der Togt coordinated the daily process. L Hol drafted the report; L Hol and C Looman performed the statistical analyses; all the collaborators listed above were given an opportunity to comment on the paper.
Trial steering committee
L Hol, ME van Leerdam, M van Ballegooijen, AJ van Vuuren, JCIY Reijerink, ACM van der Togt, JDF Habbema and EJ Kuipers.
Trial advisory board
JW Coebergh, A Cats and IMA Joung.
Provenance and Peer review Not commissioned; externally peer reviewed.
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