We propose to assess the accuracy of MRI in a multicenter diagnostic accuracy study that will include a consecutive series of patients from the general population with suspected acute appendicitis. Patient acceptance and cost-effectiveness will also…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity, specificity, predictive values of MRI for acute appendicitis
Secondary outcome
Inter-observer variability, patient acceptance, and cost-effectiveness.
Background summary
In the Netherlands 30,000 individuals are suspected with acute appendicitis
annually. The clinical diagnosis acute appendicitis is plagued by high negative
appendectomy rates (10% to 41%) and missed diagnoses (12%). Ultrasound (US) and
computed tomography (CT) are widely used to substantiate the clinical
diagnosis. US has considerable limitations in accuracy, as it generates too
many false negative results. Although CT is more accurate, this technique is
still inaccurate in 12% of patients and results in considerable ionizing
radiation exposure in often young individuals.
MRI could be an alternative form of imaging. MRI (1) is more accurate than US
and possibly CT, (2) uses no ionizing radiation, (3) and requires no contrast
agent. So far, MRI has been studied in series limited in size, primarily
including selected (pregnant) patients with substantial differences in
prevalence (10% versus the usual 60%) and with a spectrum of disease
substantially different from general clinical practice. These results do not
justify introducing MRI as first line imaging technique.
Study objective
We propose to assess the accuracy of MRI in a multicenter diagnostic accuracy
study that will include a consecutive series of patients from the general
population with suspected acute appendicitis. Patient acceptance and
cost-effectiveness will also be evaluated.
Study design
A multicenter diagnostic accuracy study in which the included patients undergo
imaging according to the draft Dutch acute appendicitis guideline: initial US
in all and subsequent CT in non diagnostic US cases (i.e. US not confirming
acute appendicitis). MRI is performed in all patients, but not used for patient
management. Reference standard is the final diagnosis assigned by an expert
panel, based on all available information including 3-months follow-up, except
MRI findings. Study period is two years (17 months inclusion period).
Intervention
MRI
Study burden and risks
MRI is a non-invasive examination without ionizing radiation. Hereby
participating in this study is associated with minor burden and risks. The
burden for the patients is mainly caused by waiting for and undergoing the MRI
scan. However, all MRI scan will be performed within two hours. The MRI scan
itself will be made in approximately 30 minuten, of which the patient will
spend approximately 15 minutes within the MRI machine.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Clinically suspected appendicitis
Exclusion criteria
Age <18 years
Pregnancy
Critically ill patients that need intensive vital organ function monitoring for life-support (for example patients in shock)
Patients with a contra-indication for MRI (pacemaker, claustrofobia)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29694.018.09 |