Acute AppendicitisNCT04518436
Diffusion MRI in Appendicitis
An observational study of Acute Appendicitis, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to investigate the effect of diffusion-weighted magnetic resonance imaging on diagnosis and surgical decision in patients with suspected acute appendicitis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Appendicitis
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 Jun 2020
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were admitted to the Department of General Surgery and Emergency Medicine with right lower quadrant pain of the abdomen, between January 2015 and May 2019, and scanned by diffusion weighted magnetic resonance imaging
Who may be able to join
- Patients with suspected acute appendicitis and scanned by diffusion weighted magnetic resonance imaging
Who cannot join
- Patients evaluated by CT
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffusion-Weighted Magnetic Resonance Imaging on Surgical Decision-Making in Acute Appendicitis
In this study, it was aimed to investigate the effect of diffusion-weighted magnetic resonance imaging on diagnosis and surgical decision in patients with suspected acute appendicitis. Investigators believe that Diffusion-weighted magnetic resonance imaging is a valuable method in the diagnosis of acute appendicitis and in making the decision of surgery.
- Conditions
- Acute Appendicitis
- Keywords
- Acute appendicitis, Diffusion weighted magnetic resonance imaging, Diagnostic accuracy
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion weighted magnetic resonance imaging
diffusion restriction
Measured: preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Jan 2015
- Primary completion1 May 2020
- Study completion1 Jun 2020
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.
- 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
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gül Bora Makal, Yuksek Ihtisas University
- Investigators
- Gül BORA MAKAL, Study director, Asist. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518436
- Sponsor's protocol ID
- observational
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared in a publication when it is possible
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-Weighted Magnetic Resonance Imaging on Surgical Decision-Making in Acute Appendicitis
- ClinicalTrials.gov ID
- NCT04518436
- Acronym / sponsor ID
- observational
- Conditions
- Acute Appendicitis
- Keywords
- Acute appendicitis, Diffusion weighted magnetic resonance imaging, Diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 19 Aug 2020 (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.
In this study, it was aimed to investigate the effect of diffusion-weighted magnetic resonance imaging on diagnosis and surgical decision in patients with suspected acute appendicitis. Investigators believe that Diffusion-weighted magnetic resonance imaging is a valuable method in the diagnosis of acute appendicitis and in making the decision of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were admitted to the Department of General Surgery and Emergency Medicine with right lower quadrant pain of the abdomen, between January 2015 and May 2019, and scanned by diffusion weighted magnetic resonance imaging
Key inclusion criteria (1 listed)
- Patients with suspected acute appendicitis and scanned by diffusion weighted magnetic resonance imaging
Key exclusion criteria (2 listed)
- Patients evaluated by CT
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diffusion weighted magnetic resonance imaging
Time frame: preoperative period
diffusion restriction
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 20 Aug 2020.
- Individual participant dataSharing planned: Undecided. IPD will be shared in a publication when it is possible
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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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Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
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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.
Gül BORA MAKAL study director
Asist. Prof.
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 Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
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 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 20 Aug 2020. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
Diffusion weighted magnetic resonance imaging (time frame: preoperative period). It is what the study was designed to measure, not a finding.
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 20 Aug 2020.