One-time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon

N Engl J Med. 2001 Aug 23;345(8):555-60. doi: 10.1056/NEJMoa010328.


Background: Fecal occult-blood testing and sigmoidoscopy have been recommended for screening for colorectal cancer, but the sensitivity of such combined testing for detecting neoplasia is uncertain. At 13 Veterans Affairs medical centers, we performed colonoscopy to determine the prevalence of neoplasia and the sensitivity of one-time screening with a fecal occult-blood test plus sigmoidoscopy.

Methods: Asymptomatic subjects (age range, 50 to 75 years) provided stool specimens on cards from three consecutive days for fecal occult-blood testing, which were rehydrated for interpretation. They then underwent colonoscopy. Sigmoidoscopy was defined in this study as examination of the rectum and sigmoid colon during colonoscopy, and sensitivity was estimated by determining how many patients with advanced neoplasia had an adenoma in the rectum or sigmoid colon. Advanced colonic neoplasia was defined as an adenoma 10 mm or more in diameter, a villous adenoma, an adenoma with high-grade dysplasia, or invasive cancer. Classification of subjects according to the findings was based on the most advanced lesion.

Results: A total of 2885 subjects returned the three specimen cards for fecal occult-blood testing and underwent a complete colonoscopic examination. A total of 23.9 percent of subjects with advanced neoplasia had a positive test for fecal occult blood. As compared with subjects who had a negative test for fecal occult blood, the relative risk of advanced neoplasia in subjects who had a positive test was 3.47 (95 percent confidence interval, 2.76 to 4.35). Sigmoidoscopy identified 70.3 percent of all subjects with advanced neoplasia. Combined one-time screening with a fecal occult-blood test and sigmoidoscopy identified 75.8 percent of subjects with advanced neoplasia.

Conclusions: One-time screening with both a fecal occult-blood test with rehydration and sigmoidoscopy fails to detect advanced colonic neoplasia in 24 percent of subjects with the condition.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adenoma / diagnosis*
  • Adenoma / pathology
  • Aged
  • Colonic Neoplasms / diagnosis*
  • Colonic Neoplasms / pathology
  • Colonic Polyps / diagnosis
  • Colonoscopy
  • Colorectal Neoplasms / diagnosis
  • Diagnostic Errors
  • Female
  • Humans
  • Male
  • Mass Screening / methods
  • Middle Aged
  • Neoplasm Invasiveness
  • Occult Blood*
  • Predictive Value of Tests
  • Sensitivity and Specificity
  • Sigmoidoscopy*