Abdominal imaging
Diagnostic TestAbdominal ultrasound and/or abdominal CT
NCT Number: NCT06083064
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
HUS, Jorvi Hospital, Espoo, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Abdominal ultrasound and/or abdominal CT
Abdominal imaging is done selectively based on Adult Appendicitis Score
Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging
Time frame: Within 30 days from randomization
Number of negative appendectomies (surgical removal of non-inflamed appendix)
Time frame: Within 30 days from randomization
Number of patients with complicated appendicitis (AAST grade 3 or higher)
Time frame: Within 30 days from randomization
Number of patients with histologically proven appendicitis undergoing surgery
Time frame: Within 30 days from randomization
Number of patients having abdominal computed tomography
Time frame: Within one year from randomization
Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)
Time frame: Within 2 years from randomization
Number of patients diagnosed with appendicitis
Time frame: During the first 30 days from randomization
Quality of life determined by weekly EQ-5D-5L index values.
Time frame: During the first 30 days from randomization
Quality of life determined by weekly EQ-5D-5L EQ-VAS score.
Time frame: During the first 30 days from randomization
Overall costs of diagnostics and treatment
Contact information is provided by the study sponsor or research team.
Helsinki University Central Hospital
Other
Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
Acronym: PROSECCO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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