Clinical trial NCT06083064: Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis
Official title: Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appendicitis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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

Primary outcomes:
measure: Negative appendectomy
timeFrame: Within 30 days from randomization
measure: Complicated appendicitis
timeFrame: Within 30 days from randomization
Secondary outcomes:
measure: histologically proven appendicitis
timeFrame: Within 30 days from randomization
measure: CT scan
timeFrame: Within 30 days from randomization
measure: Adverse events
timeFrame: Within one year from randomization
measure: Appendicitis
timeFrame: Within 2 years from randomization
measure: Quality of life (EQ-5D-5L index value)
timeFrame: During the first 30 days from randomization
measure: Quality of life (EQ-5D-5L EQ-VAS score)
timeFrame: During the first 30 days from randomization
measure: Costs in Euros
timeFrame: During the first 30 days from randomization
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: HUS, Jorvi Hospital
city: Helsinki
country: Finland
facility: HUS, Meilahti Hospital
city: Hyvinkää
country: Finland
facility: HUS, Hyvinkää Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Panu Mentula, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.