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Potentially Serious Adverse Events at CT Colonography in Symptomatic Patients: National Survey of the United Kingdom¹

¹ From the Department of Specialist Radiology, Podium Level 2, University College Hospital, Euston Road, London NW1 2BU, England. Received June 30, 2005; revision requested August 26; revision received September 28; final version accepted October 12. Address correspondence to S.H.

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.

© RSNA, 2006