Evidence of Benefit
Table 3. Randomized Controlled Screening Trials: Fecal Occult Blood Testing continued...
The NORCCAP once-only screening study randomly assigned 20,780 men and women, aged 50 to 64 years, to FS only or a combination of FS and FOBT with FlexSure OBT. A positive FS was defined as a finding of any neoplasia or any polyp at least 10 mm. A positive FS or FOBT qualified for colonoscopy. Attendance in this study was 65%. Forty-one cases of CRC were detected (0.3% of screened individuals). Adenomas were found in 2,208 participants (17%), and 545 (4.2%) had high-risk adenomas. There was no difference in diagnosis yield between the FS only and the FS and FOBT groups regarding CRC or high-risk adenoma. There were no serious complications after FS, but there were six perforations after therapeutic colonoscopy (1:336).
As part of the National Polyp Study, colonoscopic examination and barium enema were compared in paired surveillance examinations in those who had undergone a prior colonoscopic polypectomy. The proportion of examinations in which adenomatous polyps were detected by barium enema was related to the size of the adenoma (P = .009); the rate was 32% for colonoscopic examinations in which the largest adenomas detected were no larger than 5 mm, 53% for those in which the largest adenomas detected were 6 mm to 10 mm, and 48% for those in which the largest adenomas detected were larger than 10 mm. In patients who have undergone colonoscopic polypectomy, colonoscopic examination is a more sensitive method of surveillance than double-contrast barium enema.
Because there are no RCTs of colonoscopy, evidence of benefit is indirect. Most indirect evidence is about detection rate of lesions that may be clinically important (like early CRC or advanced adenomas). Some case-control results are available. One RCT of colonoscopy has been initiated.
Evidence about lesion detection rate
In a colonoscopic study of 3,121 predominantly male U.S. veterans (mean age: 63 years), advanced neoplasia (defined as an adenoma that was ≥10.0 mm in diameter, a villous adenoma, an adenoma with high-grade dysplasia, or invasive cancer) was identified in 10.5% of the individuals. Among patients with no adenomas distal to the splenic flexure, 2.7% had advanced proximal neoplasia. Patients with large adenomas (≥10.0 mm) or small adenomas (<10.0 mm) in the distal colon were more likely to have advanced proximal neoplasia than were patients with no distal adenomas (OR = 3.4; 90% CI, 1.8–6.5 and OR = 2.6; 90% CI, 1.7–4.1, respectively). One-half of those with advanced proximal neoplasia, however, had no distal adenomas. In a study of 1,994 adults (aged 50 years or older) who underwent colonoscopic screening as part of a program sponsored by an employer, 5.6% had advanced neoplasms. Forty-six percent of those with advanced proximal neoplasms had no distal polyps (hyperplastic or adenomatous). If colonoscopic screening is performed only in patients with distal polyps, about half the cases of advanced proximal neoplasia will not be detected.