Appendicitis
Conditions
Brief summary
The goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question\[s\] it aims to answer are: * Does protocol based selective imaging using clinical scoring affect clinical outcome? * Does protocol based selective observation combined with score based selective imaging affect clinical outcome? Participants will be randomized into three groups: * Selective imaging based on Adult Appendicitis Score * Selective observation based on Appendicitis Severity Score combined with selective imaging based on Adult Appendicitis Score * Routine imaging using ultrasound and/or computed tomography Researchers will compare selective imaging groups separately with routine imaging to see if number of negative appendectomies or number of complicated appendicitis is not significantly increased.
Interventions
DIAGNOSTIC_TESTAbdominal imaging
Abdominal ultrasound and/or abdominal CT
OTHERScore based selective abdominal imaging
Abdominal imaging is done selectively based on Adult Appendicitis Score
OTHERScore based selective observation combined with selective abdominal imaging
Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
1:1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Suspicion of appendicitis
Exclusion criteria
* Time from symptom onset over 72 hours * Age \<18 years * Pregnancy, ruled out by serum or urine HCG measurement in 18- to 49-year-old women * CT-scan or ultrasound already done within the last 3 days (72 hours) * Clinical suspicion of other disease or other reason to perform imaging study * Recruited earlier to the same trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative appendectomy | Within 30 days from randomization | Number of negative appendectomies (surgical removal of non-inflamed appendix) |
| Complicated appendicitis | Within 30 days from randomization | Number of patients with complicated appendicitis (AAST grade 3 or higher) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| histologically proven appendicitis | Within 30 days from randomization | Number of patients with histologically proven appendicitis undergoing surgery |
| CT scan | Within 30 days from randomization | Number of patients having abdominal computed tomography |
| Adverse events | Within one year from randomization | Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis) |
| Appendicitis | Within 2 years from randomization | Number of patients diagnosed with appendicitis |
| Quality of life (EQ-5D-5L index value) | During the first 30 days from randomization | Quality of life determined by weekly EQ-5D-5L index values. |
| Quality of life (EQ-5D-5L EQ-VAS score) | During the first 30 days from randomization | Quality of life determined by weekly EQ-5D-5L EQ-VAS score. |
| Costs in Euros | During the first 30 days from randomization | Overall costs of diagnostics and treatment |
Countries
Finland
Contacts
CONTACTPanu Mentula, MD
PRINCIPAL_INVESTIGATORPanu Mentula, MD
Helsinki University Central Hospital
Outcome results
None listed