Atkin W S, Hart A, Edwards R, McIntyre P, Aubrey R, Wardle J, Sutton S, Cuzick J, Northover J M
ICRF Colorectal Cancer Unit, St Mark's Hospital, Harrow, Middlesex, UK.
Gut. 1998 Apr;42(4):560-5. doi: 10.1136/gut.42.4.560.
A multicentre randomised controlled trial to evaluate screening by "once only" flexible sigmoidoscopy (FS) for prevention of bowel cancer is in progress.
To pilot the trial protocol examining rates of attendance, yield of neoplasia, and adverse effects.
A total of 3540 subjects aged 55-64 years in Welwyn Garden City (WGC) and 19,706 in Leicester (LE).
Subjects responding positively to an "interest in screening" questionnaire were randomised to invitation for screening or control arms. Small polyps were removed during screening. Colonoscopy was undertaken for high risk polyps (more than two adenomas, size at least 1 cm, villous histology, severe dysplasia, or malignancy). The remainder were discharged.
In WGC and LE respectively, 59% and 61% indicated an interest in screening, of which 74% and 75% attended. Adenomas were detected in 10% and 9%, respectively, and cancers in 7 per 1000 (in both centres), 55% at Dukes's stage A. The colonoscopy referral rate was 6% in both centres. Mild, short lived bleeding occurred in 3%. One person died following surgery.
Compliance rates, yield of adenomas, and referral rate for colonoscopy were as expected, but cancer detection rates were higher. Adverse effects following sigmoidoscopy or colonoscopy were mild and transient, but there was one postoperative death. A randomised trial is necessary to evaluate fully the risks and benefits of this intervention.
一项评估“一次性”柔性乙状结肠镜检查(FS)预防肠癌的多中心随机对照试验正在进行中。
试行该试验方案,检查参与率、肿瘤检出率和不良反应。
韦林花园城(WGC)共有3540名年龄在55 - 64岁的受试者,莱斯特(LE)有19706名。
对“有筛查意愿”问卷回答为肯定的受试者被随机分为筛查邀请组或对照组。筛查期间切除小息肉。对高危息肉(两个以上腺瘤、大小至少1厘米、绒毛状组织学、重度发育异常或恶性肿瘤)进行结肠镜检查。其余受试者出院。
在WGC和LE,分别有59%和61%表示有筛查意愿,其中74%和75%参与了筛查。腺瘤检出率分别为10%和9%,癌症检出率为每1000人中有7例(两个中心均如此),55%为杜克氏A期。两个中心的结肠镜转诊率均为6%。3%的受试者出现轻微、短暂的出血。1人术后死亡。
参与率、腺瘤检出率和结肠镜转诊率符合预期,但癌症检出率更高。乙状结肠镜检查或结肠镜检查后的不良反应轻微且短暂,但有1例术后死亡。有必要进行随机试验以全面评估该干预措施的风险和益处。