Potentially serious adverse events at CT colonography in symptomatic patients: National survey of the United Kingdom
Potentially serious adverse events at CT colonography in symptomatic patients: National survey of the United Kingdom
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DOI：
10.1148/radiol.2392051101
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发表时间：
2006-05-01
期刊：
影响因子：
19.7
通讯作者：
Taylor, SA
中科院分区：
文献类型：
--
作者：
Burling, D;Halligan, S;Taylor, SA
目的：回顾分析有结直肠癌症状的患者行CT结肠造影术的潜在严重不良事件的发生率。材料和方法：由于该研究被认为是临床审计，不会与患者接触，因此放弃伦理批准和知情同意。通过在英国进行的一项全国性调查，确定了在日常实践中提供CT结肠成像的所有部门。访谈了所有应答科的首席胃肠放射科医生，并确定了与有结直肠癌症状的患者进行CT结肠成像相关的潜在严重不良事件的频率、进行的检查总数以及可能与穿孔相关的技术因素。在遇到潜在严重不良事件的地方，对其进行了详细的探索。对回答进行整理，并确定原始频率。结果：50个中心共进行CT结肠造影检查17067次，平均每个中心359次，范围10-3000次。目前尚无死亡报告。13名患者(1313名患者中有1名[0.08%])发生了与该手术相关的潜在严重不良事件。穿孔9例：无症状穿孔4例(44%)，有症状穿孔5例(56%)，穿孔有病因，有症状穿孔发生率为0.03%(3413例中有1例)。有1例患者需要剖腹手术。使用充气直肠气囊进行9378次检查。直肠球囊扩张相关穿孔的比例(n=6)与非直肠球囊扩张相关穿孔的比例(n=.3)无显著差异(P=.3)。结论：与CT结肠成像相关的潜在严重不良事件发生率为0.08%。
Purpose: To retrospectively determine the incidence of potentially serious adverse events associated with computed tomographic (CT) colonography performed in patients with symptoms of colorectal cancer.Materials and Methods: Ethical approval and informed consent were waived, since the study was deemed a clinical audit and patients would not be approached. With a national survey in the United Kingdom, all departments offering CT colonography in everyday practice were identified. The lead gastrointestinal radiologist from all responding departments was interviewed, and the frequency of potentially serious adverse events associated with CT colonography performed in patients with symptoms of colorectal cancer, the total number of examinations performed, and technical factors possibly related to perforation were determined. Where a potentially serious adverse event was encountered, it was explored in detail. Responses were collated, and raw frequencies were determined. Fisher exact test was used to determine differences in event rates between groups.Results: At 50 centers, 17 067 CT colonographic examinations (mean number per center, 359; range, 10-3000) were performed. No deaths were reported. Thirteen patients (one [0.08%] of 1313) had had a potentially serious adverse event related to the procedure. There were nine perforations: Four (44%) were asymptomatic and five (56%) were symptomatic, and perforation had an attributable cause, with a symptomatic perforation rate of 0.03% (one in 3413 patients). One patient required laparotomy. An inflated rectal balloon was used to perform 9378 examinations. There was no significant difference between the proportion of perforations associated with rectal balloon inflation (n = 6) and the proportion of those that were not (n = 2) (P = .3).Conclusion: Potentially serious adverse events related to CT colonography occurred in 0.08% of symptomatic patients.