Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06083064

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

Led by Helsinki University Central Hospital · Updated on 2025-03-12

900

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating different imaging approaches for adults suspected of having appendicitis to see how they affect clinical outcomes. The study compares protocol-based selective imaging using clinical scoring to routine imaging with ultrasound and/or CT scans. The main questions are whether selective imaging and selective observation combined with scoring affect outcomes like negative appendectomies or complicated appendicitis cases. Participants will be randomly assigned to one of three groups: routine imaging with ultrasound and CT as needed; selective imaging based on the Adult Appendicitis Score (AAS); or selective observation using the Appendicitis Severity Score (ASS) combined with AAS-based selective imaging. In the routine group, patients undergo ultrasound first, followed by CT if results are inconclusive, and urgent surgery if appendicitis is found. In the selective imaging group, patients with high AAS scores have surgery, those with moderate scores get imaging, and low scores are discharged. In the observation group, patients with low AAS are discharged, moderate scores are managed by ASS and observation protocols with re-evaluation, and high scores lead to surgery. During the study, participants will have imaging tests, scoring assessments, and possible observation periods. Researchers will monitor outcomes such as negative appendectomies and complicated appendicitis within 30 days of randomization, along with quality of life, costs, and adverse events up to one year. The study's total follow-up includes tracking appendicitis occurrences for up to two years. This allows evaluation of the safety and effectiveness of selective imaging protocols compared to routine imaging in suspected appendicitis cases.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspicion of appendicitis
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Symptom onset more than 72 hours ago
  • Age under 18 years
  • Pregnancy, ruled out by serum or urine HCG test in women aged 18 to 49
  • CT scan or ultrasound done within the last 3 days
  • Clinical suspicion of other disease requiring imaging
  • Previously recruited to this trial

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

Duration - Within 30 days from randomization

Participants undergo abdominal imaging and/or observation based on scoring systems to diagnose suspected appendicitis.

1 to 2 visits depending on scoring and imaging needs

Long-term Monitoring

Duration - Up to 2 years from randomization

Participants are monitored for outcomes such as appendicitis complications and quality of life following diagnostic evaluation.

Follow-up visits as needed within 30 days and up to one year

Trial Site Locations

Total: 3 locations

1

HUS, Jorvi Hospital

Espoo, Finland

Actively Recruiting

2

HUS, Meilahti Hospital

Helsinki, Finland, 00029

Actively Recruiting

3

HUS, Hyvinkää Hospital

Hyvinkää, Finland

Actively Recruiting

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Research Team

P

Panu Mentula, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Published Research Related To This Trial

DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial.

Kirsi S Lastunen, Ari K Leppäniemi, Panu J Mentula

https://pubmed.ncbi.nlm.nih.gov/35482016