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Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis

ConditionAppendicitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abdominal imaging

    Diagnostic test

    Abdominal ultrasound and/or abdominal CT

  • Score based selective abdominal imaging

    Other intervention

    Abdominal imaging is done selectively based on Adult Appendicitis Score

  • Score based selective observation combined with selective abdominal imaging

    Other intervention

    Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging

Treatment groups

900 Participants
are divided into 3 treatment groups
Group A: Routine imagingActive comparator 1 intervention
Group B: Adult Appendicitis Score based selective imagingExperimental treatment 1 intervention
Group C: Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis ScoreExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Negative appendectomy

Number of negative appendectomies (surgical removal of non-inflamed appendix)

Time frame
Within 30 days from randomization
2

Complicated appendicitis

Number of patients with complicated appendicitis (AAST grade 3 or higher)

Time frame
Within 30 days from randomization

Secondary outcomes

1

histologically proven appendicitis

Number of patients with histologically proven appendicitis undergoing surgery

Time frame
Within 30 days from randomization
2

CT scan

Number of patients having abdominal computed tomography

Time frame
Within 30 days from randomization
3

Adverse events

Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)

Time frame
Within one year from randomization
4

Appendicitis

Number of patients diagnosed with appendicitis

Time frame
Within 2 years from randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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