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 Kim & 34 others Joong 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

Research output: Contribution to journalArticle

19 Citations (Scopus)

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

Fingerprint

Appendicitis
Appendectomy
Young Adult
Randomized Controlled Trials
Tomography
Clinical Trials
Radiation

Keywords

  • Appendicitis
  • Radiation
  • Tomography
  • X-ray computed

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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

In: Trials, Vol. 15, No. 1, 28, 17.01.2014.

Research output: Contribution to journalArticle

Ahn, S, Cha, SH, Cho, HJ, Cho, JM, Cho, SW, Choi, PC, Choi, SH, Choi, YS, Chung, YH, Gu, BS, Ha, YR, Han, SK, Heo, JY, Hong, SS, Jang, SK, Kang, SB, Kim, B, Kim, CH, Kim, HJ, Kim, HJ, Kim, JH, Kim, KP, Kim, K, Kim, MK, Kim, MS, Kim, MJ, Kim, SE, Kim, YC, Kim, YH, Ko, Y, Kwon, HJ, Lee, C-H, Lee, HK, Lee, HS, Lee, JH, Lee, JE, Lee, J, Lee, KH, Lee, MH, Lee, MJ, Lee, YJ, Na, RY, Park, CJ, Park, CW, Park, JH, Park, SB, Park, YS, Shin, DH, Shin, EJ, Woo, HS, Woo, JY, Yang, HK, Yeom, SK & Yi, BH 2014, '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, vol. 15, no. 1, 28. https://doi.org/10.1186/1745-6215-15-28
Ahn, Soyeon ; Cha, Sang Hoon ; Cho, Han Jin ; Cho, Jea Min ; Cho, Seong Whi ; Choi, Pil Cho ; Choi, Sung Hyuk ; Choi, Yoo Shin ; Chung, Yong Hwan ; Gu, Bon Seung ; Ha, Young Rock ; Han, Sang Kuk ; Heo, Jae Yeon ; Hong, Seong Sook ; Jang, Suk Ki ; Kang, Sung Bum ; Kim, Bohyoung ; Kim, Cho Hee ; Kim, Ho Jung ; Kim, Hyuk Jung ; Kim, Joong Hee ; Kim, Kwang Pyo ; Kim, Kyuseok ; Kim, Mi Kyung ; Kim, Mi Sung ; Kim, Min Jeong ; Kim, Sung Eun ; Kim, Young Chul ; Kim, Young Hoon ; Ko, Yousun ; Kwon, Heon Ju ; Lee, 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 ; Na, Ri Young ; Park, Chan Jong ; Park, Chul Woo ; Park, Ji Hoon ; Park, Sung Bin ; Park, Yang Shin ; Shin, Dong Hyuk ; Shin, Eun Jung ; Woo, Hyun Sik ; Woo, Ji Young ; Yang, Hyun Kyung ; Yeom, Suk Keu ; Yi, Boem Ha. / 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. In: Trials. 2014 ; Vol. 15, No. 1.
@article{2df09cb386a64345a95b7b673c79b750,
title = "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",
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.",
keywords = "Appendicitis, Radiation, Tomography, X-ray computed",
author = "Soyeon Ahn and Cha, {Sang Hoon} and Cho, {Han Jin} and Cho, {Jea Min} and Cho, {Seong Whi} and Choi, {Pil Cho} and Choi, {Sung Hyuk} and Choi, {Yoo Shin} and Chung, {Yong Hwan} and Gu, {Bon Seung} and Ha, {Young Rock} and Han, {Sang Kuk} and Heo, {Jae Yeon} and Hong, {Seong Sook} and Jang, {Suk Ki} and Kang, {Sung Bum} and Bohyoung Kim and Kim, {Cho Hee} and Kim, {Ho Jung} and Kim, {Hyuk Jung} and Kim, {Joong Hee} and Kim, {Kwang Pyo} and Kyuseok Kim and Kim, {Mi Kyung} and Kim, {Mi Sung} and Kim, {Min Jeong} and Kim, {Sung Eun} and Kim, {Young Chul} and Kim, {Young Hoon} and Yousun Ko and Kwon, {Heon Ju} and Chang-Hee Lee and Lee, {Hae Kyung} and Lee, {Hye Seung} and Lee, {Jae Hyuk} and Lee, {Ji Eun} and Jongmee Lee and Lee, {Kyoung Ho} and Lee, {Min Hee} and Lee, {Min Jung} and Lee, {Yoon Jin} and Na, {Ri Young} and Park, {Chan Jong} and Park, {Chul Woo} and Park, {Ji Hoon} and Park, {Sung Bin} and Park, {Yang Shin} and Shin, {Dong Hyuk} and Shin, {Eun Jung} and Woo, {Hyun Sik} and Woo, {Ji Young} and Yang, {Hyun Kyung} and Yeom, {Suk Keu} and Yi, {Boem Ha}",
year = "2014",
month = "1",
day = "17",
doi = "10.1186/1745-6215-15-28",
language = "English",
volume = "15",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - 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

T2 - Study protocol for a randomized controlled trial

AU - Ahn, Soyeon

AU - Cha, Sang Hoon

AU - Cho, Han Jin

AU - Cho, Jea Min

AU - Cho, Seong Whi

AU - Choi, Pil Cho

AU - Choi, Sung Hyuk

AU - Choi, Yoo Shin

AU - Chung, Yong Hwan

AU - Gu, Bon Seung

AU - Ha, Young Rock

AU - Han, Sang Kuk

AU - Heo, Jae Yeon

AU - Hong, Seong Sook

AU - Jang, Suk Ki

AU - Kang, Sung Bum

AU - Kim, Bohyoung

AU - Kim, Cho Hee

AU - Kim, Ho Jung

AU - Kim, Hyuk Jung

AU - Kim, Joong Hee

AU - Kim, Kwang Pyo

AU - Kim, Kyuseok

AU - Kim, Mi Kyung

AU - Kim, Mi Sung

AU - Kim, Min Jeong

AU - Kim, Sung Eun

AU - Kim, Young Chul

AU - Kim, Young Hoon

AU - Ko, Yousun

AU - Kwon, Heon Ju

AU - Lee, Chang-Hee

AU - Lee, Hae Kyung

AU - Lee, Hye Seung

AU - Lee, Jae Hyuk

AU - Lee, Ji Eun

AU - Lee, Jongmee

AU - Lee, Kyoung Ho

AU - Lee, Min Hee

AU - Lee, Min Jung

AU - Lee, Yoon Jin

AU - Na, Ri Young

AU - Park, Chan Jong

AU - Park, Chul Woo

AU - Park, Ji Hoon

AU - Park, Sung Bin

AU - Park, Yang Shin

AU - Shin, Dong Hyuk

AU - Shin, Eun Jung

AU - Woo, Hyun Sik

AU - Woo, Ji Young

AU - Yang, Hyun Kyung

AU - Yeom, Suk Keu

AU - Yi, Boem Ha

PY - 2014/1/17

Y1 - 2014/1/17

N2 - 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.

AB - 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.

KW - Appendicitis

KW - Radiation

KW - Tomography

KW - X-ray computed

UR - http://www.scopus.com/inward/record.url?scp=84892461920&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84892461920&partnerID=8YFLogxK

U2 - 10.1186/1745-6215-15-28

DO - 10.1186/1745-6215-15-28

M3 - Article

VL - 15

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 28

ER -