Acute AppendicitisNCT05815446
Non Contrast CT in Acute Appendicitis
An observational study of Acute Appendicitis, run by Assiut University.
Trial summary
To evaluate Diagnostic accuracy of Non-contrast CT in correlation with ultrasound in diagnosis of acute appendicitis in adults Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- CT
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2023to 30 Dec 2023
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: This study will be applied upon all patient referred from the emergency ward with clinical suspicious of acute appendicitis during the period from April 2023 to December 2023. Patients should fulfill the following criteria.
Who may be able to join
- Adult patient (male or female) with clinical suspicion of acute appendicitis .
Who cannot join
- pregnant ladies and patients with history of appendectomy
About this study
Official title: Diagnostic Accuracy of Non-Contrast Computed Tomography in Correlation With Ultrasound in Detecting Acute Appendicitis in Adults
To evaluate Diagnostic accuracy of Non-contrast CT in correlation with ultrasound in diagnosis of acute appendicitis in adults
Read the detailed description
Acute appendicitis is a prevalent cause of abdominal pain, with an estimated lifetime risk of 7 to 9%.[1] Diagnosing appendicitis on CT has a sensitivity and specificity of 87% and 76%, respectively. Classically, diagnosis of acute appendicitis is by identifying an enlarged appendix (greater than 6 mm in diameter) .
Some studies suggest using a cut-off value of over 7 mm to improve the prognostic capability of CT.
On the other hand, appendicitis is regularly diagnosed using radiology studies. In fact, imaging is often the deciding factor between operative and non-operative management. Though the diagnosis can be clinical following a thorough history and physical, imaging is regularly employed to confirm the diagnosis in question. The most commonly used radiographic study is the CT scan, given its speed, sensitivity, and specificity. US is also relatively useful modality to diagnose acute appendicitis, it has its limitations. Ultrasound is highly operator dependent and tends to work best on individuals with less fat and muscle content in their abdomen (i.e., children). Currently, the negative appendectomy is less than 12% in men but can be up to 33% in women; accurate imaging studies could reduce the number of unnecessary surgeries performed on patients. It is, therefore, essential to know which study will provide the clinician with the most accurate information for their specific clinical scenario.
- Conditions
- Acute Appendicitis
- Being tested
- CT
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDevice
NON CONTASR COMPUTED TOMOGRAPHY
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of non contrast CT in correlation with ultrasound in acute appendicitis .
Diagnostic Accuracy of Non-Contrast Computed Tomography in Correlation with Ultrasound in Detecting Acute Appendicitis in Adults.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Apr 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Omar Mohamed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815446
- Sponsor's protocol ID
- CT in acute appendicitis
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen CI. A case report: periodontal surgery in Parkinsonism utilizing intravenous sedation. N Y State Dent J. 1978 Jan;44(1):19. No abstract available.
PubMed 271274Drazen JM. Asthma therapy with agents preventing leukotriene synthesis or action. Proc Assoc Am Physicians. 1999 Nov-Dec;111(6):547-59. doi: 10.1046/j.1525-1381.1999.t01-1-99242.x.
PubMed 10591083
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Non-Contrast Computed Tomography in Correlation With Ultrasound in Detecting Acute Appendicitis in Adults
- ClinicalTrials.gov ID
- NCT05815446
- Acronym / sponsor ID
- CT in acute appendicitis
- Conditions
- Acute Appendicitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 18 Apr 2023 (actual)
- 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.
To evaluate Diagnostic accuracy of Non-contrast CT in correlation with ultrasound in diagnosis of acute appendicitis in adults
Detailed description
Acute appendicitis is a prevalent cause of abdominal pain, with an estimated lifetime risk of 7 to 9%.[1] Diagnosing appendicitis on CT has a sensitivity and specificity of 87% and 76%, respectively. Classically, diagnosis of acute appendicitis is by identifying an enlarged appendix (greater than 6 mm in diameter) .
Some studies suggest using a cut-off value of over 7 mm to improve the prognostic capability of CT.
On the other hand, appendicitis is regularly diagnosed using radiology studies. In fact, imaging is often the deciding factor between operative and non-operative management. Though the diagnosis can be clinical following a thorough history and physical, imaging is regularly employed to confirm the diagnosis in question. The most commonly used radiographic study is the CT scan, given its speed, sensitivity, and specificity. US is also relatively useful modality to diagnose acute appendicitis, it has its limitations. Ultrasound is highly operator dependent and tends to work best on individuals with less fat and muscle content in their abdomen (i.e., children). Currently, the negative appendectomy is less than 12% in men but can be up to 33% in women; accurate imaging studies could reduce the number of unnecessary surgeries performed on patients. It is, therefore, essential to know which study will provide the clinician with the most accurate information for their specific clinical scenario.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will be applied upon all patient referred from the emergency ward with clinical suspicious of acute appendicitis during the period from April 2023 to December 2023. Patients should fulfill the following criteria.
Key inclusion criteria (1 listed)
- Adult patient (male or female) with clinical suspicion of acute appendicitis .
Key exclusion criteria (1 listed)
- pregnant ladies and patients with history of appendectomy
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 |
|---|---|---|
| CTNON CONTASR COMPUTED TOMOGRAPHY | Device | – |
Primary outcome
accuracy of non contrast CT in correlation with ultrasound in acute appendicitis .
Time frame: baseline
Diagnostic Accuracy of Non-Contrast Computed Tomography in Correlation with Ultrasound in Detecting Acute Appendicitis in Adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 271274Cohen CI. A case report: periodontal surgery in Parkinsonism utilizing intravenous sedation. N Y State Dent J. 1978 Jan;44(1):19. No abstract available.
- Background: PubMed 10591083Drazen JM. Asthma therapy with agents preventing leukotriene synthesis or action. Proc Assoc Am Physicians. 1999 Nov-Dec;111(6):547-59. doi: 10.1046/j.1525-1381.1999.t01-1-99242.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
accuracy of non contrast CT in correlation with ultrasound in acute appendicitis . (time frame: baseline). 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 NCT05815446, which also lists 2 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 25 Apr 2023.