Appendicitis
Conditions
Brief summary
The aim of the study is to evaluate whether patients with early equivocal appendicitis can be observed instead of immediate diagnostic imaging. Half of the patients are randomly assigned to observation group, while the other half will undergo diagnostic imaging. The hypothesis is that resolving appendicitis is common in these patients. Thus, in observation group there will be fewer patients with appendicitis diagnosis and observation reduces the use of diagnostic imaging and surgery.
Detailed description
For the study equivocal appendicitis is defined as clinical suspicion of appendicitis with Adult Appendicitis Score between 11 and 15. The estimated prevalence of appendicitis in such patients is around 50%. Diagnostic imaging is done using conditional computed tomography i.e. abdominal ultrasound first and computed tomography only after negative or inconclusive appendicitis after ultrasound. In observation group repeated clinical examination is done after 6-8 hours interval with repeated blood test for calculation of Adult Appendicitis Score. Patients with decreasing score value continue observation without imaging, whereas patients with the same score value or higher (but below 16) undergo diagnostic imaging as in other group. Laparoscopy is done without imaging in patients with high score (16 or higher). Antibiotics are not allowed, but prophylactic antibiotics during induction of anesthesia are allowed.
Interventions
OTHERDiagnostic imaging
Abdominal ultrasound, followed by abdominal computed tomography when necessary
OTHERObservation
Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical suspicion of acute appendicitis * Equivocal appendicitis defined by Adult Appendicitis Score: Score ≥11 and ≤15.
Exclusion criteria
* C-reactive protein \>99 mg/l * Time from symptom onset over 24 hours * Pregnancy * Antibiotics given within last 24 hours * Suspicion of other disease than appendicitis, that would require immediate interventions such as surgery, diagnostic imaging or gynecologic consultation * Missing written informed consent * Patient randomized earlier to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Appendicitis requiring surgery or other intervention | 30 days from randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed appendicitis diagnosis | 30 days from randomization | Diagnosis is delayed if appendicitis is diagnosed later than 24 hours from randomization |
| Number of diagnostic imaging studies needed | 30 days from randomization and within 1 year after randomization | Number of abdominal ultrasound and abdominal computed tomography per patient |
| Appendicitis requiring surgery or other intervention | within 1 year after randomization | — |
| Negative appendectomy | 30 days from randomization | Laparoscopy done for suspected appendicitis, but patient does not have appendicitis |
| Complicated appendicitis | 30 days from randomization | Perforated appendicitis or appendiceal abscess |
| Number of other clinically relevant findings | 30 days from randomization | Findings unrelated to appendicitis |
| Number of patients requiring of gynecological consultation | 30 days from randomization | Applicable only in female patients |
| Time for decision | 30 days from randomization | The time from randomization to either decision to operate in appendicitis patients or to discharge in non-appendicitis patients. |
| Number of re-admissions to emergency unit | 1 year | Any reason for re-admission are accounted |
Countries
Finland
Outcome results
None listed