NCT01925014

Brief Summary

To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,074

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

August 15, 2013

Results QC Date

June 11, 2017

Last Update Submit

August 21, 2018

Conditions

Appendicitis

Keywords

AppendectomyAppendicitisFalse Positive ReactionsHumansRadiation DosageTomography, X-Ray ComputedYoung Adult

Outcome Measures

Primary Outcomes (1)

  • Negative Appendectomy Rate

    Negative appendectomy rate was defined as the percentage of negative (unnecessary) appendectomies among all non-incidental appendectomies. As a secondary analysis, negative appendectomy rate in an alternative definition was calculated by excluding cases with appendiceal neoplasms without superimposed appendicitis, as appendectomy would be clinically necessary in such patients. Any surgery performed for the treatment of presumed appendicitis was counted as non-incidental appendectomy, even though the surgical procedures were more extensive than simple appendectomy (e.g., ileocectomy).

    1 week after surgery

Secondary Outcomes (14)

  • Appendiceal Perforation Rate

    1 week after surgery

  • Number of Appendectomies

    3 months after CT

  • Number of Negative Appendectomies

    1 week after surgery

  • Prevalence of Perforated Appendicitis

    1 week after surgery

  • Prevalence of Non-perforated Appendicitis

    1 week after surgery

  • +9 more secondary outcomes

Study Arms (2)

Low-dose CT

EXPERIMENTAL

Diagnostic CT with low-dose radiation

Diagnostic Test: Diagnostic CT with low-dose radiation

Standard-dose CT

ACTIVE COMPARATOR

Diagnostic CT with standard-dose radiation

Diagnostic Test: Diagnostic CT with standard-dose radiation

Interventions

Diagnostic CT with low-dose radiationDIAGNOSTIC_TEST

Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.

Also known as: Low-dose CT
Low-dose CT
Diagnostic CT with standard-dose radiationDIAGNOSTIC_TEST

Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.

Also known as: Standard-dose CT
Standard-dose CT

Eligibility Criteria

Age15 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Emergency department visit with suspected symptoms and signs of acute appendicitis
  • Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
  • Willing to provide telephone or cell phone numbers for follow-up
  • Signed informed consent provided prior to study entry

You may not qualify if:

  • Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs
  • Prior history of surgical removal of the appendix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Kangwon National University Hospital

Chuncheon, Gangwon-do, 200-722, South Korea

Location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

Wonkwang University Sanbon Hospital

Sanbon, Gyeonggi-do, 435-040, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Daejin Medical Center, Bundang Jesaeng General Hospital

Seongnam-si, Gyeonggi-do, 463-774, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Wonkwang University School of Medicine & Hospital

Iksan, 570-711, South Korea

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Jeju National University Hospital

Jeju City, 690-767, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Soonchunhyang University Seoul Hospital

Seoul, 140-887, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 150-950, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

Related Publications (6)

  • 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 Apr 26;366(17):1596-605. doi: 10.1056/NEJMoa1110734.

    PMID: 22533576BACKGROUND

  • Ahn S; LOCAT group. 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. 2014 Jan 17;15:28. doi: 10.1186/1745-6215-15-28.

    PMID: 24438500BACKGROUND

  • Ko Y, Choi JW, Kim DH, Lee KJ, Shin SS, Woo JY, Cho SW, Kim BS, Lee KH. Central image archiving and management system for multicenter clinical studies: lessons from low-dose CT for appendicitis trial. J Korean Soc Radiol. 2017 Mar 28;76(3):165-72. doi: 10.3348/jksr.2017.76.3.165.

    BACKGROUND

  • Yang HK, Ko Y, Lee MH, Woo H, Ahn S, Kim B, Pickhardt PJ, Kim MS, Park SB, Lee KH; Low-Dose CT for Appendicitis Trial (LOCAT) Group. Initial Performance of Radiologists and Radiology Residents in Interpreting Low-Dose (2-mSv) Appendiceal CT. AJR Am J Roentgenol. 2015 Dec;205(6):W594-611. doi: 10.2214/AJR.15.14513.

    PMID: 26587949BACKGROUND

  • Kim HY, Lee S, Kim DH, Ko Y, Park JH, Ko A, Jeong SM, Park SB, Lee KH; LOCAT Group. Conventional-Dose CT Versus 2-mSv CT for Right Colonic Diverticulitis as an Alternate Diagnosis of Appendicitis: Secondary Analysis of Large Pragmatic Randomized Trial Data. AJR Am J Roentgenol. 2021 Nov;217(5):1113-1121. doi: 10.2214/AJR.21.25584. Epub 2021 Apr 7.

    PMID: 33825498DERIVED

  • LOCAT Group. Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):793-804. doi: 10.1016/S2468-1253(17)30247-9. Epub 2017 Sep 12.

    PMID: 28919126DERIVED

Related Links

MeSH Terms

Conditions

Appendicitis

Interventions

Radiation

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

Title
Kyoung Ho Lee
Organization
The LOCAT Group
kholeemail@gmail.com
82317877607

Study Officials

  • Kyoung Ho Lee, MD

    Seoul National University Bundang Hospital

    STUDY CHAIR

  • Kyuseok Kim, MD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 19, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

January 31, 2019

Results First Posted

January 31, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

The LOCAT Group has an active standpoint for sharing the LOCAT data, which is in line with the proposal from the International Committee of Medical Journal Editors. The LOCAT Group will share de-identified individual-participant data underlying the main LOCAT results no later than 6 months after the publication of the results. The data will be kept in a publicly available website and freely available to anyone upon request.

Locations

KR(20)