284 Laparoscopic Antireflux Surgery vs Long-Term Esomeprazole Treatment for Chronic GERD. Final Results After 5 Yrs of Follow up in the Lotus Study

Abstract

Introduction A once-only flexible sigmoidoscopy (FS) screening at age around 60 has been proposed as a cost-effective and acceptable method of reducing colorectal cancer (CRC) incidence and mortality. We undertook a large randomised controlled trial in a general population sample to compare CRC incidence and mortality rates following a single FS screen. Methods and baseline results Between 1994 and 1999, we sent a questionnaire to 375 744 men and women, aged 55 to 64 years, in 14 UK centres, asking whether they would have the FS screening if invited. Those who responded ‘yes definitely' or ‘yes probably' and were found to be eligible (n = 170 432) were randomised to the control or intervention arms of the trial in a 2:1 ratio. Of 57 254 people invited, 40 674 (71%) were screened. Following screening, 38 525 (95%) had either no pathology or only low-risk adenomas and were discharged and 2051 had high risk adenomas detected and underwent colonoscopy. Biannual updates on status (emigration, cancer diagnoses or deaths) were obtained by matching with the National Health Service Central Register, Office of National Statistics, UK cancer registries, and Hospitals Episodes Statistics records. Results of follow-up The median follow-up time to death, emigration or 31st December 2008 is currently 11 years. A total of 2491 participants developed CRC during 1.85 million person years of follow-up: 1523 developed a distal cancer (rectum or sigmoid colon), 894 developed cancer in the proximal colon, 34 developed cancer in both sites, and in 40 cases the site was not known. On an intent-to-treat analysis, a significant reduction in incidence of total and distal CRC was observed among those invited for screening. A greater reduction was seen among those who attended for screening. Colorectal cancer mortality rates were also reduced significantly. Adjustment for self-selection bias in attenders using Cuzick et al's method (Stat Med 1997;16:1017-29) made little difference to the rate ratios or significance. Conclusion By 11 years, total and distal colorectal cancer incidence rates were reduced significantly among people offered a single flexible sigmoidoscopy screen between ages 55 and 64 years, and so far no attenuation of effect has been observed. Detailed results will be presented.