Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Jun 5;168(11):775-782.
doi: 10.7326/M17-1441. Epub 2018 Apr 24.

Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A Randomized Trial

Øyvind Holme  1 , Magnus Løberg  1 , Mette Kalager  2 , Michael Bretthauer  1 , Miguel A Hernán  2 , Eline Aas  3 , Tor J Eide  1 , Eva Skovlund  4 , Jon Lekven  5 , Jörn Schneede  6 , Kjell Magne Tveit  7 , Morten Vatn  7 , Giske Ursin  8 , Geir Hoff  9 ; NORCCAP Study Group†
Collaborators, Affiliations
Randomized Controlled Trial

Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A Randomized Trial

Øyvind Holme et al. Ann Intern Med. .

Abstract

Background: The long-term effects of sigmoidoscopy screening on colorectal cancer (CRC) incidence and mortality in women and men are unclear.

Objective: To determine the effectiveness of flexible sigmoidoscopy screening after 15 years of follow-up in women and men.

Design: Randomized controlled trial. (ClinicalTrials.gov: NCT00119912).

Setting: Oslo and Telemark County, Norway.

Participants: Adults aged 50 to 64 years at baseline without prior CRC.

Intervention: Screening (between 1999 and 2001) with flexible sigmoidoscopy with and without additional fecal blood testing versus no screening. Participants with positive screening results were offered colonoscopy.

Measurements: Age-adjusted CRC incidence and mortality stratified by sex.

Results: Of 98 678 persons, 20 552 were randomly assigned to screening and 78 126 to no screening. Adherence rates were 64.7% in women and 61.4% in men. Median follow-up was 14.8 years. The absolute risks for CRC in women were 1.86% in the screening group and 2.05% in the control group (risk difference, -0.19 percentage point [95% CI, -0.49 to 0.11 percentage point]; HR, 0.92 [CI, 0.79 to 1.07]). In men, the corresponding risks were 1.72% and 2.50%, respectively (risk difference, -0.78 percentage point [CI, -1.08 to -0.48 percentage points]; hazard ratio [HR], 0.66 [CI, 0.57 to 0.78]) (P for heterogeneity = 0.004). The absolute risks for death from CRC in women were 0.60% in the screening group and 0.59% in the control group (risk difference, 0.01 percentage point [CI, -0.16 to 0.18 percentage point]; HR, 1.01 [CI, 0.77 to 1.33]). The corresponding risks for death from CRC in men were 0.49% and 0.81%, respectively (risk difference, -0.33 percentage point [CI, -0.49 to -0.16 percentage point]; HR, 0.63 [CI, 0.47 to 0.83]) (P for heterogeneity = 0.014).

Limitation: Follow-up through national registries.

Conclusion: Offering sigmoidoscopy screening in Norway reduced CRC incidence and mortality in men but had little or no effect in women.

Primary funding source: Norwegian government and Norwegian Cancer Society.

PubMed Disclaimer

Conflict of interest statement

Disclosures: All authors report no conflicts of interest.

Figures

Appendix Figure 1
Appendix Figure 1
Study flow chart. CRC = colorectal cancer; FOBT = fecal occult blood testing.
Appendix Figure 2
Appendix Figure 2
Risks for CRC, rectosigmoid cancer, and death from CRC for women and men in the screening and control groups. CRC = colorectal cancer.
Appendix Figure 3
Appendix Figure 3
Fifteen-year risks for CRC and death from CRC with and without screening for women and men. CRC = colorectal cancer.
Figure 1:
Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and women in the screening and control groups.
Panel A: colorectal cancer risk in women; Panel B: colorectal cancer risk in men; Panel C: rectosigmoid cancer risk in women; Panel D: rectosigmoid cancer risk in men; Panel E: colorectal cancer mortality risk in women; Panel F: colorectal cancer mortality risk in men
Figure 1:
Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and women in the screening and control groups.
Panel A: colorectal cancer risk in women; Panel B: colorectal cancer risk in men; Panel C: rectosigmoid cancer risk in women; Panel D: rectosigmoid cancer risk in men; Panel E: colorectal cancer mortality risk in women; Panel F: colorectal cancer mortality risk in men
Figure 1:
Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and women in the screening and control groups.
Panel A: colorectal cancer risk in women; Panel B: colorectal cancer risk in men; Panel C: rectosigmoid cancer risk in women; Panel D: rectosigmoid cancer risk in men; Panel E: colorectal cancer mortality risk in women; Panel F: colorectal cancer mortality risk in men
Figure 2:
Figure 2:
15-year risks of colorectal cancer (light-blue) and colorectal cancer mortality (dark blue) with and without screening for men and women
See this image and copyright information in PMC

Comment in

References

    1. USPSTF, Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr., et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564–75. - PubMed
    1. Atkin W, Wooldrage K, Parkin DM, Kralj-Hans I, MacRae E, Shah U, et al. Long term effects of once-only flexible sigmoidoscopy screening after 17 years of follow-up: the UK Flexible Sigmoidoscopy Screening randomised controlled trial. Lancet. 2017. - PMC - PubMed
    1. Holme O, Loberg M, Kalager M, Bretthauer M, Hernan MA, Aas E, et al. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA. 2014;312(6):606–15. - PMC - PubMed
    1. Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, et al. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. New England Journal of Medicine. 2012;366(25):2345–57. - PMC - PubMed
    1. Segnan N, Armaroli P, Bonelli L, Risio M, Sciallero S, Zappa M, et al. Once-only sigmoidoscopy in colorectal cancer screening: follow-up findings of the Italian Randomized Controlled Trial--SCORE. J Natl Cancer Inst. 2011;103(17):1310–22. - PubMed

Publication types

Associated data