AppendicitisPhase 3NCT00913380
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
A Phase 3 study testing Diagnostic CT in people with Appendicitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy. 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 891 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Apr 2011
- Phase
- Phase 3
- 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
- Suspected of having acute appendicitis
- Referred for abdomen CT from Emergency Department
Who cannot join
- Body mass index < 18.5 kg/m2 (ultrasonography is favored)
- Intravenous contrast-enhancement is contraindicated
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.
Read the detailed description
Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is an established first-line diagnostic test in patients suspected of having acute appendicitis. Since many individuals suspected of having acute appendicitis are young, with a mean age of 30 years, CT radiation is of particular concern.
The estimated lifetime attributable risk of death from cancer due to the radiation exposure of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age.
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the negative appendectomy rate.
- Conditions
- Appendicitis
- Being tested
- Diagnostic CT
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic CTRadiation
Also called low-dose CT
2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
Diagnostic CTRadiation
Also called standard-dose CT
8 mSv in an average patient (Standard-dose CT)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose CT | Experimental | Not described Receives: Radiation: Diagnostic CT |
| Standard-dose CT | Active comparator | Not described Receives: Radiation: Diagnostic CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Appendectomy
Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)
Measured: 1 week after surgery
Secondary outcomes (9)
Additional Imaging Test(s)
Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis
Measured: 1 week after CT
Appendiceal Perforation
Number of participants with appendiceal perforation
Measured: 1 week after surgery
Interval Between CT and Appendectomy
Time interval between the CT acquisition and non-incidental appendectomy
Measured: 1 day after surgery
Interval Between CT and Discharge Without Surgery
Time interval between the CT acquisition and discharge without surgery
Measured: 3 months after CT
Interval From CT to Discharge After Appendectomy
Time interval between the CT acquisition and discharge after appendectomy
Measured: 3 months after CT
Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis
Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.
Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence.
Measured: 3 months after CT
Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis
Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.
Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence.
Measured: 3 months after CT
Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.
True positive: Perforation was rated as present in CT report and confirmed as present.
False positive: Perforation was rated as present in CT report and confirmed as absent.
True negative: Perforation was rated as absent in CT report and confirmed as absent.
False negative: Perforation was rated as absent in CT report and confirmed as present.
The data are used to calculate sensitivity and specificity.
Measured: 3 months after CT
Visualization of the Normal Appendix
Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized
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 posted4 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionApr 2011
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 (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, National Research Foundation of Korea
- Responsible party
- Principal investigator, Kyoung Ho Lee, Seoul National University Bundang Hospital
- Investigators
- Kyoung Ho Lee, MD, Principal investigator, Seoul National University Bundang HospitalKyuseok Kim, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913380
- Sponsor's protocol ID
- SNUBH-LDCTinAPPY
- Status last verified
- Sep 2011
- First submitted
- 15 May 2009
- Last updated
- 12 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 22533576
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
- ClinicalTrials.gov ID
- NCT00913380
- Acronym / sponsor ID
- SNUBH-LDCTinAPPY
- Conditions
- Appendicitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 891 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare, National Research Foundation of Korea
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 2 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.
Detailed description
Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is an established first-line diagnostic test in patients suspected of having acute appendicitis. Since many individuals suspected of having acute appendicitis are young, with a mean age of 30 years, CT radiation is of particular concern.
The estimated lifetime attributable risk of death from cancer due to the radiation exposure of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age.
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the negative appendectomy rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose CT | Experimental | Radiation: Diagnostic CT |
| Standard-dose CT | Active comparator | Radiation: Diagnostic CT |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Suspected of having acute appendicitis
- Referred for abdomen CT from Emergency Department
Key exclusion criteria (2 listed)
- Body mass index < 18.5 kg/m2 (ultrasonography is favored)
- Intravenous contrast-enhancement is contraindicated
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 CTAlso: low-dose CT2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose)) | Radiation | Low-dose CT |
| Diagnostic CTAlso: standard-dose CT8 mSv in an average patient (Standard-dose CT) | Radiation | Standard-dose CT |
Primary outcome
Negative Appendectomy
Time frame: 1 week after surgery
Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)
9 secondary outcomes
Additional Imaging Test(s)
Time frame: 1 week after CT
Appendiceal Perforation
Time frame: 1 week after surgery
Interval Between CT and Appendectomy
Time frame: 1 day after surgery
Interval Between CT and Discharge Without Surgery
Time frame: 3 months after CT
Interval From CT to Discharge After Appendectomy
Time frame: 3 months after CT
Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis
Time frame: 3 months after CT
Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis
Time frame: 3 months after CT
Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.
Time frame: 3 months after CT
Visualization of the Normal Appendix
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 12 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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 principal investigator
Seoul National University Bundang Hospital
Kyuseok Kim, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diagnostic CT in people with Appendicitis, run by Seoul National University Bundang Hospital at 1 site 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 2 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 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2011). 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 (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 NCT00913380, which also lists 1 linked publication.
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 12 Sep 2011.