LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: Study protocol for a randomized controlled trial

Soyeon Ahn, Sang Hoon Cha, Han Jin Cho, Jea Min Cho, Seong Whi Cho, Pil Cho Choi, Sung Hyuk Choi, Yoo Shin Choi, Yong Hwan Chung, Bon Seung Gu, Young Rock Ha, Sang Kuk Han, Jae Yeon Heo, Seong Sook Hong, Suk Ki Jang, Sung Bum Kang, Bohyoung Kim, Cho Hee Kim, Ho Jung Kim, Hyuk Jung KimJoong Hee Kim, Kwang Pyo Kim, Kyuseok Kim, Mi Kyung Kim, Mi Sung Kim, Min Jeong Kim, Sung Eun Kim, Young Chul Kim, Young Hoon Kim, Yousun Ko, Heon Ju Kwon, Chang Hee Lee, Hae Kyung Lee, Hye Seung Lee, Jae Hyuk Lee, Ji Eun Lee, Jongmee Lee, Kyoung Ho Lee, Min Hee Lee, Min Jung Lee, Yoon Jin Lee, Ri Young Na, Chan Jong Park, Chul Woo Park, Ji Hoon Park, Sung Bin Park, Yang Shin Park, Dong Hyuk Shin, Eun Jung Shin, Hyun Sik Woo, Ji Young Woo, Hyun Kyung Yang, Suk Keu Yeom, Boem Ha Yi

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Abstract

Background: Computed tomography is widely used to diagnose acute appendicitis. Many adolescents and young adults are exposed to the associated radiation. A recent single-institution trial has reported promising results for low-dose computed tomography; however, this technique has not yet been widely adopted. LOCAT (low-dose computed tomography for appendicitis trial), a multi-institution randomized controlled non-inferiority trial, aims to compare low-dose computed tomography and standard-dose computed tomography as the first-line imaging tests for adolescents and young adults, and therefore to test the generalizability of the previous single-institution trial results.Methods/Design: Participants with suspected appendicitis are randomly assigned to either the low-dose group (with a typical effective dose of 2 mSv) or the standard-dose group (as used in normal practice at each participating site, typically 8 mSv). The primary end point is the negative appendectomy rate (the percentage of the number of uninflamed appendices that were removed among all non-incidental appendectomies), which is a consequence of false-positive diagnoses, with a non-inferiority margin of 4.5 percentage points. The key secondary end point is the appendiceal perforation rate, which is a consequence of delayed (or false-negative) diagnoses. Participant recruitment will be continued until the number of non-incidental appendectomies for each group exceeds 444. The total number of expected participants approximates 3,000, including those not undergoing appendectomy.Discussion: In addition to the study protocol, we elaborate on several challenging or potentially debatable components of the study design, including the broad eligibility criteria, choice of the primary end point, potential effect of using advanced imaging techniques on study results, determining and adjusting the radiation doses, ambiguities in reference standards, rationale for the non-inferiority margin, use of the intention-to-treat approach and difficulties in defining adverse events.Trial registration: ClinicalTrials.gov NCT01925014.

Original languageEnglish
Article number28
JournalTrials
Volume15
Issue number1
DOIs
Publication statusPublished - 2014 Jan 17
Externally publishedYes

Bibliographical note

Funding Information:
LOCAT is funded by the Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea (HI13C00040200), the Medical Research Collaborating Center, Seoul National University Bundang Hospital (02-2013-091) and Dasol Life Science Inc (06-2013-107), all of which have no role other than funding. LOCAT is supported by Korean Society of Abdominal Radiology and Korean Society of Radiology Center for Clinical Research. LOCAT is a collaborative effort by the LOCAT Group: 1. Soyeon Ahn, Seoul National University Bundang Hospital 2. Sang Hoon Cha, Korea University Ansan Hospital 3. Han Jin Cho, Korea University Ansan Hospital 4. Jea Min Cho, Seoul National University 5. Seong Whi Cho, Kangwon National University Hospital 6. Pil Cho Choi, Kangbuk Samsung Medical Center 7. Sung Hyuk Choi, Korea University Guro Hospital 8. Yoo Shin Choi, Chung-Ang University Hospital 9. Yong Hwan Chung, Seoul National University Bundang Hospital 10. Bon Seung Gu, Seoul National University Bundang Hospital 11. Young Rock Ha, Daejin Medical Center, Bundang Jesaeng General Hospital 12. Sang Kuk Han, Kangbuk Samsung Medical Center 13. Jae Yeon Heo, LOCAT Office Staff 14. Seong Sook Hong, Soonchunhyang University Hospital 15. Suk Ki Jang, Daejin Medical Center, Bundang Jesaeng General Hospital 16. Sung-Bum Kang, Seoul National University Bundang Hospital 17. Bohyoung Kim, Seoul National University Bundang Hospital 18. Cho Hee Kim, LOCAT Office Staff 19. Ho Jung Kim, Soonchunhyang University Bucheon Hospital 20. Hyuk Jung Kim, Daejin Medical Center Bundang Jesaeng General Hospital 21. Joong Hee Kim, Seoul National University Bundang Hospital 22. Kwang Pyo Kim, Kyung Hee University 23. Kyuseok Kim, Seoul National University Bundang Hospital 24. Mi Kyung Kim, Chung-Ang University Hospital 25. Mi Sung Kim, Kangbuk Samsung Medical Center 26. Min-Jeong Kim, Hallym University Sacred Heart Hospital 27. Sung Eun Kim, Chung-Ang University Hospital 28. Young Chul Kim, Ajou University Hospital 29. Young Hoon Kim, Seoul National University Bundang Hospital 30. Yousun Ko, Seoul National University Bundang Hospital 31. Heon-Ju Kwon, Kangbuk Samsung Medical Center 32. Chang Hee Lee, Korea University Guro Hospital 33. Hae Kyung Lee, Soonchunhyang University Bucheon Hospital 34. Hye Seung Lee, Seoul National University Bundang Hospital 35. Jae Hyuk Lee, Seoul National University Bundang Hospital 36. Ji Eun Lee, LOCAT Office Staff 37. Jongmee Lee, Korea University Guro Hospital 38. Kyoung Ho Lee, Seoul National University Bundang Hospital 39. Min Hee Lee, Soonchunhyang University Bucheon Hospital 40. Min Jung Lee, LOCAT Office Staff 41. Yoon Jin Lee, Seoul National University Bundang Hospital 42. Ri Young Na, LOCAT Office Staff 43. Chan Jong Park, Seoul National University Bundang Hospital 44. Chul Woo Park, Kangwon National University Hospital 45. Ji Hoon Park, Seoul National University Bundang Hospital 46. Sung Bin Park, Chung-Ang University Hospital 47. Yang Shin Park, Korea University Guro Hospital 48. Dong Hyuk Shin, Kangbuk Samsung Medical Center 49. Eun Jung Shin, LOCAT Office Staff 50. Hyun Sik Woo, SMG-SNU Boramae Medical Center 51. Ji Young Woo, Hallym University Kangnam Sacred Heart Hospital 52. Hyun Kyung Yang, Seoul National University Bundang Hospital 53. Suk Keu Yeom, Korea University Ansan Hospital 54. Boem Ha Yi, Soonchunhyang University Bucheon Hospital

Keywords

  • Appendicitis
  • Radiation
  • Tomography
  • X-ray computed

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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