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

Trials

Volumn 15, Issue 1, 2014, Pages

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

^a Seoul National University Bundang Hospital   (South Korea)

^b Korea University   (South Korea)

^c Seoul National University   (South Korea)

^d Kangwon National University   (South Korea)

^e Samsung Medical Center   (South Korea)

^f Korea University College of Medicine   (South Korea)

^g Chung Ang University College of Medicine   (South Korea)

^h Bundang Jesaeng Hospital   (South Korea)

ⁱ Soonchunhyang University College of Medicine   (South Korea)

^j Soonchunhyang University   (South Korea)

^k Kyung Hee University   (South Korea)

^l Hallym University   (South Korea)

^m Ajou University Medical CentSuwon   (South Korea)

ⁿ Seoul National University Boramae Hospital   (South Korea)

^o SMG SNU Boramae Medical Center ^*

more..

Author keywords

Appendicitis; Radiation; Tomography; X ray computed

Indexed keywords

ACUTE APPENDICITIS; ADOLESCENT; ADULT; APPENDECTOMY; APPENDIX PERFORATION; ARTICLE; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; RADIATION DOSE; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT;

ADOLESCENT; ADULT; AGE FACTORS; APPENDECTOMY; APPENDICITIS; CLINICAL PROTOCOLS; HUMANS; INTENTION TO TREAT ANALYSIS; PREDICTIVE VALUE OF TESTS; RADIATION DOSAGE; REPUBLIC OF KOREA; RESEARCH DESIGN; SINGLE-BLIND METHOD; TOMOGRAPHY, X-RAY COMPUTED; UNNECESSARY PROCEDURES; YOUNG ADULT;

EID: 84892461920     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-28     Document Type: Article

References (63)

1. Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol 1990, 132:910-925.
2. Terasawa T, Blackmore CC, Bent S, Kohlwes RJ. Systematic review: computed tomography and ultrasonography to detect acute appendicitis in adults and adolescents. Ann Intern Med 2004, 141:537-546. 10.7326/0003-4819-141-7-200410050-00011, 15466771.
3. van Randen A, Bipat S, Zwinderman AH, Ubbink DT, Stoker J, Boermeester MA. Acute appendicitis: meta-analysis of diagnostic performance of CT and graded compression US related to prevalence of disease. Radiology 2008, 249:97-106. 10.1148/radiol.2483071652, 18682583.
4. Drake FT, Florence MG, Johnson MG, Jurkovich GJ, Kwon S, Schmidt Z, Thirlby RC, Flum DR, Collaborative S. Progress in the diagnosis of appendicitis: a report from Washington State's Surgical Care and Outcomes Assessment Program. Ann Surg 2012, 256:586-594. 10.1097/SLA.0b013e31826a9602, 3475492, 22964731.
5. Raja AS, Wright C, Sodickson AD, Zane RD, Schiff GD, Hanson R, Baeyens PF, Khorasani R. Negative appendectomy rate in the era of CT: an 18-year perspective. Radiology 2010, 256:460-465. 10.1148/radiol.10091570, 20529988.
6. Coursey CA, Nelson RC, Patel MB, Cochran C, Dodd LG, Delong DM, Beam CA, Vaslef S. Making the diagnosis of acute appendicitis: do more preoperative CT scans mean fewer negative appendectomies? A 10-year study. Radiology 2010, 254:460-468. 10.1148/radiol.09082298, 20093517.
7. Paulson EK, Kalady MF, Pappas TN. Clinical practice. Suspected appendicitis. N Engl J Med 2003, 348:236-242. 10.1056/NEJMcp013351, 12529465.
8. Flum DR, Morris A, Koepsell T, Dellinger EP. Has misdiagnosis of appendicitis decreased over time? A population-based analysis. JAMA 2001, 286:1748-1753. 10.1001/jama.286.14.1748, 11594900.
9. Raman SS, Osuagwu FC, Kadell B, Cryer H, Sayre J, Lu DS. Effect of CT on false positive diagnosis of appendicitis and perforation. N Engl J Med 2008, 358:972-973. 10.1056/NEJMc0707000, 18305278.
10. Rao PM, Rhea JT, Rattner DW, Venus LG, Novelline RA. Introduction of appendiceal CT: impact on negative appendectomy and appendiceal perforation rates. Ann Surg 1999, 229:344-349. 10.1097/00000658-199903000-00007, 1191699, 10077046.
11. Cuschieri J, Florence M, Flum DR, Jurkovich GJ, Lin P, Steele SR, Symons RG, Thirlby R. Negative appendectomy and imaging accuracy in the Washington State Surgical Care and Outcomes Assessment Program. Ann Surg 2008, 248:557-563.
12. Rhea JT, Halpern EF, Ptak T, Lawrason JN, Sacknoff R, Novelline RA. The status of appendiceal CT in an urban medical center 5 years after its introduction: experience with 753 patients. Am J Roentgenol 2005, 184:1802-1808.
13. Rao PM, Rhea JT, Novelline RA, Mostafavi AA, McCabe CJ. Effect of computed tomography of the appendix on treatment of patients and use of hospital resources. N Engl J Med 1998, 338:141-146. 10.1056/NEJM199801153380301, 9428814.
14. National Health Insuarance Service 2011 statistics on major surgeries in Korea. http://www.bokjiro.go.kr/data/statusView.do?board_sid=297&data_sid=5999111, National Health Insuarance Service.
15. Budhraja V. Radiation exposure from medical imaging procedures. N Engl J Med 2009, 361:2290-2291. Author's reply 2291-2292.
16. Karnath BM, Luh JY. Suspected appendicitis. N Engl J Med 2003, 349:305-306. Author's reply 305-306.
17. Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Craft AW, Parker L, Berrington de Gonzalez A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet 2012, 380:499-505. 10.1016/S0140-6736(12)60815-0, 3418594, 22681860.
18. Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington De Gonzalez A, Miglioretti DL. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med 2009, 169:2078-2086. 10.1001/archinternmed.2009.427, 20008690.
19. Brenner DJ, Hall EJ. Computed tomography - an increasing source of radiation exposure. N Engl J Med 2007, 357:2277-2284. 10.1056/NEJMra072149, 18046031.
20. Berrington De Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med 2009, 169:2071-2077. 10.1001/archinternmed.2009.440, 20008689.
21. Tsapaki V, Rehani M, Saini S. Radiation safety in abdominal computed tomography. Semin Ultrasound CT MR 2010, 31:29-38. 10.1053/j.sult.2009.09.004, 20102693.
22. Johnson PT, Horton KM, Mahesh M, Fishman EK. Multidetector computed tomography for suspected appendicitis: multi-institutional survey of 16-MDCT data acquisition protocols and review of pertinent literature. J Comput Assist Tomogr 2006, 30:758-764. 10.1097/01.rct.0000228156.65904.b4, 16954924.
23. Keyzer C, Tack D, de Maertelaer V, Bohy P, Gevenois PA, Van Gansbeke D. Acute appendicitis: comparison of low-dose and standard-dose unenhanced multi-detector row CT. Radiology 2004, 232:164-172. 10.1148/radiol.2321031115, 15155894.
24. Kim SY, Lee KH, Kim K, Kim TY, Lee HS, Hwang SS, Song KJ, Kang HS, Kim YH, Rhee JE. Acute appendicitis in young adults: low- versus standard-radiation-dose contrast-enhanced abdominal CT for diagnosis. Radiology 2011, 260:437-445. 10.1148/radiol.11102247, 21633052.
25. Seo H, Lee KH, Kim HJ, Kim K, Kang SB, Kim SY, Kim YH. Diagnosis of acute appendicitis with sliding slab ray-sum interpretation of low-dose unenhanced CT and standard-dose intravenous contrast-enhanced CT scans. Am J Roentgenol 2009, 193:96-105.
26. Kim K, Kim YH, Kim SY, Kim S, Lee YJ, Kim KP, Lee HS, Ahn S, Kim T, Hwang SS, Song KJ, Kang SB, Kim DW, Park SH, Lee KH. Low-dose abdominal CT for evaluating suspected appendicitis. N Engl J Med 2012, 366:1596-1605. 10.1056/NEJMoa1110734, 22533576.
27. Korean Good Clinical Practice Guideline. http://www.law.go.kr/lsBylInfoR.do?bylSeq=4818056&lsiSeq=137939#AJAX.
28. Huda W, Mettler FA. Volume CT dose index and dose-length product displayed during CT: what good are they?. Radiology 2011, 258:236-242. 10.1148/radiol.10100297, 20971777.
29. Kalra MK, Maher MM, Toth TL, Schmidt B, Westerman BL, Morgan HT, Saini S. Techniques and applications of automatic tube current modulation for CT. Radiology 2004, 233:649-657. 10.1148/radiol.2333031150, 15498896.
30. Deak PD, Smal Y, Kalender WA. Multisection CT protocols: sex- and age-specific conversion factors used to determine effective dose from dose-length product. Radiology 2010, 257:158-166. 10.1148/radiol.10100047, 20851940.
31. Joo S-M, Lee KH, Kim YH, Kim SY, Kim K, Kim KJ, Kim B. Detection of the normal appendix with low-dose unenhanced CT: use of the sliding slab averaging technique. Radiology 2009, 251:780-787. 10.1148/radiol.2513081617, 19336669.
32. Schauer DA, Linton OW. NCRP Report No. 160, Ionizing Radiation Exposure of the Population of the United States, medical exposure - are we doing less with more, and is there a role for health physicists?. Health Phys 2009, 97:1-5. 10.1097/01.HP.0000356672.44380.b7, 19509507.
33. Brix G, Nagel HD, Stamm G, Veit R, Lechel U, Griebel J, Galanski M. Radiation exposure in multi-slice versus single-slice spiral CT: results of a nationwide survey. Eur Radiol 2003, 13:1979-1991. 10.1007/s00330-003-1883-y, 12687286.
34. Hart D, Wall BF, Hiller MC, Shrimpton PC. Frequency and Collective Dose for Medical and Dental X-ray Examinations in the UK, 2008, HPA-CECE-012 2010, Health Protection Agency: Chilton.
35. Bankier AA, Kressel HY. Through the Looking Glass revisited: the need for more meaning and less drama in the reporting of dose and dose reduction in CT. Radiology 2012, 265:4-8. 10.1148/radiol.12121145, 22993216.
36. Kim B, Lee KH, Kim KJ, Mantiuk R, Kim HR, Kim YH. Artifacts in slab average-intensity-projection images reformatted from JPEG 2000 compressed thin-section abdominal CT data sets. Am J Roentgenol 2008, 190:W342-350.
37. Lee KH, Hong H, Hahn S, Kim B, Kim KJ, Kim YH. Summation or axial slab average intensity projection of abdominal thin-section CT datasets: can they substitute for the primary reconstruction from raw projection data?. J Digit Imaging 2008, 21:422-432. 10.1007/s10278-007-9067-y, 3043854, 17805929.
38. von Falck C, Galanski M, Shin HO. Informatics in radiology: sliding-thin-slab averaging for improved depiction of low-contrast lesions with radiation dose savings at thin-section CT. Radiographics 2010, 30:317-326. 10.1148/rg.302096007, 20068000.
39. Birnbaum BA, Wilson SR. Appendicitis at the millennium. Radiology 2000, 215:337-348. 10.1148/radiology.215.2.r00ma24337, 10796905.
40. Sim JY, Kim HJ, Yeon JW, Suh BS, Kim KH, Ha YR, Paik SY. Added value of ultrasound re-evaluation for patients with equivocal CT findings of acute appendicitis: a preliminary study. Eur Radiol 2013, 23:1882-1890. 10.1007/s00330-013-2769-2, 23392792.
41. Rosai J. Appendix. Rosai and Ackerman's Surgical Pathology 2004, 758-759. Edinburgh, UK: Mosby, Rosai J.
42. Fenoglio-Preiser CM, Noffsinger AE, Stemmermann GN, Lantz PE, Isaacson PG. Nonneoplastic Diseases of the Appendix. Gastrointestinal Pathology 2008, 504-505. Philadelphia, PA: Lippincott Williams & Wilkins, Fenoglio-Preiser CM, Noffsinger AE, Stemmermann GN, Lantz PE, Isaacson PG, 3.
43. Lally KP, Cox CS, Andrassy RJ. Appendix. Sabiston Textbook of Surgery: The Biological Basis of Modern Surgical Practice 2004, 1382. Philadelphia, PA: Elsevier Saunders, Townsend CM, Beauchamp RD, Evers BM, Mattox KL, 17.
44. Kim K, Lee CC, Song KJ, Kim W, Suh G, Singer AJ. The impact of helical computed tomography on the negative appendectomy rate: a multi-center comparison. J Emerg Med 2008, 34:3-6. 10.1016/j.jemermed.2007.05.042, 18022782.
45. Common terminology criteria for adverse events version 4.0. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40.
46. Wagner JM, McKinney WP, Carpenter JL. Does this patient have appendicitis?. JAMA 1996, 276:1589-1594. 10.1001/jama.1996.03540190061030, 8918857.
47. Andersson RE. Meta-analysis of the clinical and laboratory diagnosis of appendicitis. Br J Surg 2004, 91:28-37. 10.1002/bjs.4464, 14716790.
48. Lameris W, van Randen A, Go PM, Bouma WH, Donkervoort SC, Bossuyt PM, Stoker J, Boermeester MA. Single and combined diagnostic value of clinical features and laboratory tests in acute appendicitis. Acad Emerg Med 2009, 16:835-842. 10.1111/j.1553-2712.2009.00486.x, 19689484.
49. Leeuwenburgh MMN. Appendicitis is easily missed or wrongly diagnosed - imaging is needed. BMJ 2011, 343:d5976. 10.1136/bmj.d5976, 21980077.
50. Weston AR, Jackson TJ, Blamey S. Diagnosis of appendicitis in adults by ultrasonography or computed tomography: a systematic review and meta-analysis. Int J Technol Assess Health Care 2005, 21:368-379.
51. Gilmore T, Jordan C, Edelstein E. Right-sided diverticulitis mimics appendicitis. J Emerg Med 2013, 44:e29-32. 10.1016/j.jemermed.2011.06.035, 21996286.
52. Kim JH, Cheon JH, Park S, Kim BC, Lee SK, Kim TI, Kim WH. Relationship between disease location and age, obesity, and complications in Korean patients with acute diverticulitis: a comparison of clinical patterns with those of Western populations. Hepatogastroenterology 2008, 55:983-986.
53. Velanovich V, Satava R. Balancing the normal appendectomy rate with the perforated appendicitis rate: implications for quality assurance. Am Surg 1992, 58:264-269.
54. Sicard N, Tousignant P, Pineault R, Dube S. Non-patient factors related to rates of ruptured appendicitis. Br J Surg 2007, 94:214-221. 10.1002/bjs.5428, 17205491.
55. Points to consider on multiplicity issues in clinical trials. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf.
56. Lee KH, Lee HJ, Kim JH, Kang HS, Lee KW, Hong H, Chin HJ, Ha KS. Managing the CT data explosion: initial experiences of archiving volumetric datasets in a mini-PACS. J Digit Imaging 2005, 18:188-195. 10.1007/s10278-005-5163-z, 3046710, 15924274.
57. Lee KH, Kim YH, Hahn S, Lee KW, Kim TJ, Kang SB, Shin JH. Computed tomography diagnosis of acute appendicitis: advantages of reviewing thin-section datasets using sliding slab average intensity projection technique. Invest Radiol 2006, 41:579-585. 10.1097/01.rli.0000221999.22095.b7, 16772851.
58. Lee KH, Lee HS, Park SH, Bajpai V, Choi YS, Kang SB, Kim KJ, Kim YH. Appendiceal diverticulitis: diagnosis and differentiation from usual acute appendicitis using computed tomography. J Comput Assist Tomogr 2007, 31:763-769. 10.1097/RCT.0b013e3180340991, 17895789.
59. O'Leary DP, Redmond HP, Andrews EJ. Low-dose abdominal CT for diagnosing appendicitis. N Engl J Med 2012, 367:478. Author's reply 478-479.
60. Pickhardt PJ, Lawrence EM, Pooler BD, Bruce RJ. Diagnostic performance of multidetector computed tomography for suspected acute appendicitis. Ann Intern Med 2011, 154:789-796. 10.7326/0003-4819-154-12-201106210-00006, 21690593.
61. Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med 2006, 145:62-69. 10.7326/0003-4819-145-1-200607040-00011, 16818930.
62. Krajewski S, Brown J, Phang PT, Raval M, Brown CJ. Impact of computed tomography of the abdomen on clinical outcomes in patients with acute right lower quadrant pain: a meta-analysis. Can J Surg 2011, 54:43-53. 10.1503/cjs.023509, 3038359, 21251432.
63. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006, 295:1152-1160. 10.1001/jama.295.10.1152, 16522836.