Background, Aims, and Patients-In a prospective follow up and intervention study of colorectal polyps, leaving all polyps less than 10 mm in situ for three years, analysis ofredetection rate, growth, and new polyp formation was carried out in 116 patients undergoing annual colonoscopy. The findings in relation to growth and new polyp formation were applied to 58 subjects who received placebo. Results-Redetection rate varied from 75-90% for each year, and was highest in the rectum and sigmoid colon. There was no net change in size of all polyps in the placebo group, however, polyps less than 5 mm showed a tendency to net growth, and polyps 5-9 mm a tendency to net regression in size, both for adenomas and hyperplastic polyps. In a prospective intervention study of growth of colorectal polyps over three years, polyps less than 10 mm in maximal diameter were left in situ.4 Redetection rate, growth, and new detected polyps were evaluated at the first year follow up examination.5The purpose of this study was to evaluate whether the macroscopic growth pattern during the first year could be verified during the second and third year. In our previous report5 we were neither aware of the histological classification of the polyps, nor did we know which intervention medication the patients used. In this study we wanted to evaluate growth and new polyp formation only in the adenomatous polyps in the patients using placebo, to avoid a possible effect of the intervention medication. Moreover, as this is the first study leaving polyps more than 5 mm in situ, we also needed to assess the safety aspect and the feasibility of such a study after completion.
MethodsStudy subjects and design The total study included 116 patients (male/ female 59/57) aged 50-76 years at entry.4 Polyps .10 mm were removed, while the rest were left in situ for a follow up period of three years with annual colonoscopic follow up examinations or removed if they reached a size beyond 9 mm. No biopsy specimens of the polyps were taken before the end of the study. The patients received placebo or a mixture consisting of calcium and antioxidants, stratified according to the size of the polyps and block randomised, to test if the active medication was able to reduce polyp growth.4Placebo was given to 58 patients. Included in the intervention trial (published later) was a medical and family history, which showed that non-steroidal anti-inflammatory drugs (NSAIDs) and aminosalicylic acid were used Medical Department,