Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abdominal imaging, Score based selective abdominal imaging, Score based selective observation combined with selective abdominal imaging.
- Who it may be relevant to
- Registry conditions: Appendicitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
Overview
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 test Abdominal imaging
Abdominal ultrasound and/or abdominal CT - Other Score based selective abdominal imaging
Abdominal imaging is done selectively based on Adult Appendicitis Score - Other Score based selective observation combined with selective abdominal imaging
Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging
Primary outcome measures
- Negative appendectomy [Time frame: Within 30 days from randomization]
- Complicated appendicitis [Time frame: Within 30 days from randomization]
Secondary outcome measures (7)
- histologically proven appendicitis [Time frame: Within 30 days from randomization]
- CT scan [Time frame: Within 30 days from randomization]
- Adverse events [Time frame: Within one year from randomization]
- Appendicitis [Time frame: Within 2 years from randomization]
- Quality of life (EQ-5D-5L index value) [Time frame: During the first 30 days from randomization]
- Quality of life (EQ-5D-5L EQ-VAS score) [Time frame: During the first 30 days from randomization]
- Costs in Euros [Time frame: During the first 30 days from randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Finland · 3 centers
- HUS, Jorvi Hospital — Espoo
- HUS, Meilahti Hospital — Helsinki
- HUS, Hyvinkää Hospital — Hyvinkää
Publications
- Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114. PMID 24970111
- Lastunen KS, Leppaniemi AK, Mentula PJ. DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial. Br J Surg. 2022 Jun 14;109(7):588-594. doi: 10.1093/bjs/znac120. PMID 35482016
- Atema JJ, van Rossem CC, Leeuwenburgh MM, Stoker J, Boermeester MA. Scoring system to distinguish uncomplicated from complicated acute appendicitis. Br J Surg. 2015 Jul;102(8):979-90. doi: 10.1002/bjs.9835. Epub 2015 May 12. PMID 25963411
Identifiers
NCT: NCT06083064 · HUS/74/2023