Acute AppendicitisNCT01376466
Impact of CT on Diagnosis of Acute Appendicitis
An observational study of Acute Appendicitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether computed tomography is reliable investigation in the diagnosis of acute appendicitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- CT scanning
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2009to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Admitted patients with acute appendicitis.
Who may be able to join
- Patients who have been admitted and diagnosed as having acute appendicitis
Who cannot join
- Patients under the age of 18 years.
- Pregnancy.
- Uncooperative patients (senile dementia, mentally ill).
- Not speaking Danish.
- Does not wish to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact Of Computed Tomography On The Diagnoses Of Acute Appendicitis
The purpose of this study is to determine whether computed tomography is reliable investigation in the diagnosis of acute appendicitis.
Read the detailed description
The aim of this study is to
- evaluate CT scan validity for the diagnosis of acute appendicitis.
- compare the difference in evaluation of CT-scan result between radiologist on call and consultant radiologist with CT experience.
- illustrate difficulties associated with practical implementation of CT-scan in relation to other activities in radiology department and O.R. (logical \& organizational).
- illustrate patients experiences about the study (pain, discomfort \& other information
- Conditions
- Acute Appendicitis
- Being tested
- CT scanning
- Keywords
- acute appendicitis, diagnosis, computed tomography
- Medical subject headings
- Appendicitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanningOther
Also called CT scanning of the abdomen
CT image of the abdomen included the area between the 3rd. lumber vertebra and the top of acetabulum. A liter of contrast mixed with normal salin will be given by rectal catheter 20 minutes before CT image is taken.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute appendicitis | Patients who have been clinically diagnosed to have acute appendicitis Receives: Other: CT scanning |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Herning Hospital
- Responsible party
- Sponsor
- Investigators
- Mogens R Madsen, MD, Study director, Consultant surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376466
- Sponsor's protocol ID
- M-20080129
- Status last verified
- Nov 2012
- First submitted
- 17 Jun 2011
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Computed Tomography On The Diagnoses Of Acute Appendicitis
- ClinicalTrials.gov ID
- NCT01376466
- Acronym / sponsor ID
- M-20080129
- Conditions
- Acute Appendicitis
- Keywords
- acute appendicitis, diagnosis, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Herning Hospital
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
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 computed tomography is reliable investigation in the diagnosis of acute appendicitis.
Detailed description
The aim of this study is to
- evaluate CT scan validity for the diagnosis of acute appendicitis.
- compare the difference in evaluation of CT-scan result between radiologist on call and consultant radiologist with CT experience.
- illustrate difficulties associated with practical implementation of CT-scan in relation to other activities in radiology department and O.R. (logical \& organizational).
- illustrate patients experiences about the study (pain, discomfort \& other information
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute appendicitis | – | Other: CT scanningPatients who have been clinically diagnosed to have acute appendicitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted patients with acute appendicitis.
Key inclusion criteria (1 listed)
- Patients who have been admitted and diagnosed as having acute appendicitis
Key exclusion criteria (5 listed)
- Patients under the age of 18 years.
- Pregnancy.
- Uncooperative patients (senile dementia, mentally ill).
- Not speaking Danish.
- Does not wish to participate.
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 |
|---|---|---|
| CT scanningAlso: CT scanning of the abdomenCT image of the abdomen included the area between the 3rd. lumber vertebra and the top of acetabulum. A liter of contrast mixed with normal salin will be given by rectal catheter 20 minutes before CT image is taken. | Other | patients with acute appendicitis |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
Related trials for Acute Appendicitis
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Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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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.
Mogens R Madsen, MD study director
Consultant surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 5 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 9 Nov 2012. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 9 Nov 2012.