AppendicitisLOCATNCT01925014
Low vs. Standard Dose CT for Appendicitis Trial
A study testing Diagnostic CT with low-dose radiation and Diagnostic CT with standard-dose radiation in people with Appendicitis, run by Kyoung Ho Lee, MD at 20 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 44 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Diagnostic CT with low-dose radiation and Diagnostic CT with standard-dose radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,074 participants
- Where
- 20 sitesSouth Korea
- Study dates
- Dec 2013to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs
- Prior history of surgical removal of the appendix
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 425-707
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 431-070
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
Kangwon National University Hospital
Chuncheon, Gangwon-do, 200-722
Keimyung University Dongsan Medical Center
Daegu, 700-712
Chonnam National University Hospital
Gwangju, 501-757
Wonkwang University School of Medicine & Hospital
Iksan, 570-711
Gachon University Gil Medical Center
Incheon, 405-760
Jeju National University Hospital
Jeju City, 690-767
Wonkwang University Sanbon Hospital
Sanbon, Gyeonggi-do, 435-040
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Daejin Medical Center, Bundang Jesaeng General Hospital
Seongnam-si, Gyeonggi-do, 463-774
Seoul National University Hospital
Seoul, 110-744
Kangbuk Samsung Hospital
Seoul, 110-746
Severance Hospital
Seoul, 120-752
The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital
Seoul, 137-701
Soonchunhyang University Seoul Hospital
Seoul, 140-887
Hallym University Kangnam Sacred Heart Hospital
Seoul, 150-950
Korea University Guro Hospital
Seoul, 152-703
Chung-Ang University Hospital
Seoul, 156-755
About this study
Official title: A Multi-institutional Trial Comparing Clinical Outcomes Following Low- vs. Standard-dose Abdominal CT as the First-line Imaging Test in Adolescents and Young Adults With Suspected Acute Appendicitis
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).
Read the detailed description
- Acute appendicitis is a very common disease. Many patients are adolescents or young adults.
- CT is the current standard imaging test for the diagnosis of appendicitis.
- In recent years, the awareness of carcinogenic risk associated with CT radiation has increased.
- According to a recent single-institutional randomized controlled trial, LD CT (employing a quarter of standard radiation dose) was found to be noninferior to SD CT with respect to NARs in adolescents and young adults with suspected appendicitis.
- However, LD CT is not yet widely accepted.
- To establish LD CT as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.
- Conditions
- Appendicitis
- Being tested
- Diagnostic CT with low-dose radiation, Diagnostic CT with standard-dose radiation
- Keywords
- Appendectomy, Appendicitis, False Positive Reactions, Humans, Radiation Dosage, Tomography, X-Ray Computed, Young Adult
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic CT with low-dose radiationDiagnostic test
Also called Low-dose CT
Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.
Diagnostic CT with standard-dose radiationDiagnostic test
Also called Standard-dose CT
Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose CT | Experimental | Diagnostic CT with low-dose radiation Receives: Diagnostic Test: Diagnostic CT with low-dose radiation |
| Standard-dose CT | Active comparator | Diagnostic CT with standard-dose radiation Receives: Diagnostic Test: Diagnostic CT with standard-dose radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 week after surgery
Secondary outcomes (14)
Appendiceal Perforation Rate
The percentage of perforated appendicitis among confirmed appendicitis cases.
Measured: 1 week after surgery
Number of Appendectomies
Appendectomy rate. The percentage of appendectomies among all randomized cases.
Measured: 3 months after CT
Number of Negative Appendectomies
The percentage of negative appendectomies among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.
Measured: 1 week after surgery
Prevalence of Perforated Appendicitis
The percentage (i.e., prevalence) of perforated appendicitis among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.
Measured: 1 week after surgery
Prevalence of Non-perforated Appendicitis
The percentage (i.e., prevalence) of non-perforated appendicitis among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.
Measured: 1 week after surgery
Need for Additional Imaging Test(s)
The proportion of patients requiring additional imaging test(s) in order to diagnose or rule out appendicitis.
Measured: 1 week after CT
Delay in Patient Disposition
- The interval from CT acquisition to appendectomy in patients undergoing appendectomy. Interval appendectomies following percutaneous abscess drainage and/or medical treatment were not included in this analysis.
- The interval from CT acquisition to hospital discharge in patients not undergoing surgery.
Measured: 3 months after CT
Length of Hospital Stay Associated With Appendectomy
The interval from CT acquisition to hospital discharge after appendectomy.
Measured: 3 months after CT
Diagnostic Performance of CT Reports - AUC
- Area under the receiver-operating-characteristic curve (AUC).
Measured: 3 months after CT
Diagnostic Performance of CT Reports - Sensitivity and Specificity
- Diagnostic sensitivity and specificity: the 5-grade likelihood scores for appendicitis were collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
- Sensitivity is a proportion of the positive test among the patient confirmed as having appendicitis.
- Specificity is a proportion of the negative test among the patient confirmed as not having appendicitis.
Measured: 3 months after CT
Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis
- Likelihood score for appendicitis in patients confirmed as having appendicitis.
- Likelihood score for appendicitis in patients confirmed as not having appendicitis.
Grade 1 denotes appendicitis definitely absent; grade 2, appendicitis probably absent; grade 3, indeterminate for the presence of appendicitis; grade 4, appendicitis probably present; and grade 5, appendicitis definitely present.
Measured: 3 months after CT
Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3)
The frequency of indeterminate CT interpretation (grade 3). Grade 1 denotes appendicitis definitely absent; grade 2, appendicitis probably absent; grade 3, indeterminate for the presence of appendicitis; grade 4, appendicitis probably present; and grade 5, appendicitis definitely present.
Measured: 3 months after CT
Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization
The frequency of normal appendix visualization at CT. Grade 0 denotes appendix not identified; grade 1, unsure or partly visualized; and grade 2, clearly and entirely visualized.
Measured: 3 months after CT
Diagnosis of Appendiceal Perforation at CT
- Diagnostic sensitivity: the number of correct detections of the perforation divided by the number of cases of perforated appendicitis.
- Diagnostic specificity: the number of correct ruling out the perforation divided by the number of cases of appendicitis without perforation.
Measured: 3 months after CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,074 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoung Ho Lee, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Seoul National University Bundang Hospital, Radiology Imaging Network of Korea for Clinical Research, The LOCAT Group
- Responsible party
- Sponsor-investigator, Kyoung Ho Lee, MD, Seoul National University Bundang Hospital
- Investigators
- Kyoung Ho Lee, MD, Study chair, Seoul National University Bundang HospitalKyuseok Kim, MD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925014
- Sponsor's protocol ID
- LOCAT
- Acronym
- LOCAT
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2013
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 22533576Ahn 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.
PubMed 24438500Ko 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.
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.
PubMed 26587949Kim 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.
PubMed 33825498LOCAT 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.
PubMed 28919126
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-institutional Trial Comparing Clinical Outcomes Following Low- vs. Standard-dose Abdominal CT as the First-line Imaging Test in Adolescents and Young Adults With Suspected Acute Appendicitis
- ClinicalTrials.gov ID
- NCT01925014
- Acronym / sponsor ID
- LOCAT / LOCAT
- Conditions
- Appendicitis
- Keywords
- Appendectomy, Appendicitis, False Positive Reactions, Humans, Radiation Dosage, Tomography, X-Ray Computed, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,074 participants (actual)
- Lead sponsor
- Kyoung Ho Lee, MDUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Seoul National University Bundang Hospital, Radiology Imaging Network of Korea for Clinical Research, The LOCAT Group
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- Acute appendicitis is a very common disease. Many patients are adolescents or young adults.
- CT is the current standard imaging test for the diagnosis of appendicitis.
- In recent years, the awareness of carcinogenic risk associated with CT radiation has increased.
- According to a recent single-institutional randomized controlled trial, LD CT (employing a quarter of standard radiation dose) was found to be noninferior to SD CT with respect to NARs in adolescents and young adults with suspected appendicitis.
- However, LD CT is not yet widely accepted.
- To establish LD CT as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose CT | Experimental | Diagnostic Test: Diagnostic CT with low-dose radiationDiagnostic CT with low-dose radiation |
| Standard-dose CT | Active comparator | Diagnostic Test: Diagnostic CT with standard-dose radiationDiagnostic CT with standard-dose radiation |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs
- Prior history of surgical removal of the appendix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic CT with low-dose radiationAlso: Low-dose CTEffective dose is aimed at approximately 2 millisievert (mSv) in an average patient. | Diagnostic test | Low-dose CT |
| Diagnostic CT with standard-dose radiationAlso: Standard-dose CTEffective dose is aimed at approximately 8 millisievert (or less) in an average patient. | Diagnostic test | Standard-dose CT |
Primary outcome
Negative Appendectomy Rate
Time frame: 1 week after surgery
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).
14 secondary outcomes
Appendiceal Perforation Rate
Time frame: 1 week after surgery
Number of Appendectomies
Time frame: 3 months after CT
Number of Negative Appendectomies
Time frame: 1 week after surgery
Prevalence of Perforated Appendicitis
Time frame: 1 week after surgery
Prevalence of Non-perforated Appendicitis
Time frame: 1 week after surgery
Need for Additional Imaging Test(s)
Time frame: 1 week after CT
Delay in Patient Disposition
Time frame: 3 months after CT
Length of Hospital Stay Associated With Appendectomy
Time frame: 3 months after CT
Diagnostic Performance of CT Reports - AUC
Time frame: 3 months after CT
Diagnostic Performance of CT Reports - Sensitivity and Specificity
Time frame: 3 months after CT
Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis
Time frame: 3 months after CT
Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3)
Time frame: 3 months after CT
Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization
Time frame: 3 months after CT
Diagnosis of Appendiceal Perforation at CT
Time frame: 3 months after CT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22533576Kim 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.
- Background: PubMed 24438500Ahn 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.
- BackgroundKo 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: PubMed 26587949Yang 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.
- Derived from this study: PubMed 33825498Kim 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.
- Derived from this study: PubMed 28919126LOCAT 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.
- LOCAT-Training, a self-learning course to train the radiologists at all Sites to ensure the safety of the participants.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoung Ho Lee, MD study chair
Seoul National University Bundang Hospital
Kyuseok Kim, MD study director
Seoul National University Bundang Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic CT with low-dose radiation and Diagnostic CT with standard-dose radiation in people with Appendicitis, run by Kyoung Ho Lee, MD at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Appendectomy Rate (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01925014, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.