Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial
- Authors
- Kim Baek-hui; YEOM, Suk keu; CHOI, Sung Hyuk
- Issue Date
- 11월-2017
- Publisher
- ELSEVIER LTD
- Citation
- THE LANCET GASTROENTEROLOGY AND HEPATOLOGY, v.2, no.11, pp.793 - 804
- Indexed
- SCOPUS
- Journal Title
- THE LANCET GASTROENTEROLOGY AND HEPATOLOGY
- Volume
- 2
- Number
- 11
- Start Page
- 793
- End Page
- 804
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/81619
- DOI
- 10.1016/S2468-1253(17)30247-9
- ISSN
- 24681253
- Abstract
- Background CT radiation is arguably carcinogenic. Results from single-centre studies, mostly retrospective, have advocated lowering the CT radiation dose for the diagnosis of appendicitis. However, adoption of low-dose CT has been slow. We aimed to assess the effectiveness of low-dose CT compared with standard-dose CT in the diagnosis of appendicitis in adolescents and young adults. Methods We did this pragmatic, multicentre, randomised controlled non-inferiority trial at 20 South Korean teaching hospitals with little experience with low-dose CT. Patients aged 15–44 years with suspected appendicitis were randomly assigned (1:1), via computer-generated random assignments (permuted block sizes of two, four, six, and eight) concealed in sequentially numbered envelopes, to receive low-dose CT (2 mSv) or standard-dose CT (≤8 mSv). Randomisation was stratified by site. Group allocation was concealed from patients, outcome assessors, and adverse event adjudicators; care providers, site pathologists, and data collectors were aware of allocation. The primary endpoint was the negative (unnecessary) appendectomy rate among all appendectomies, with a non-interiority margin of 4·5% for low-dose versus standard-dose CT. Primary analysis was by modified intention to treat, which included all pa
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