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

Appendicitis Clinical Trial

— PROSECCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083064
• Other study ID #: HUS/74/2023
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Helsinki University Central Hospital
• Contact: Panu Mentula, MD
• Phone: 504270183
• Email: panu.mentula[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

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
• Score based selective observation combined with selective abdominal imaging
Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging

Locations

Country	Name	City	State
Finland	HUS, Jorvi Hospital	Espoo
Finland	HUS, Meilahti Hospital	Helsinki
Finland	HUS, Hyvinkää Hospital	Hyvinkää

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative appendectomy	Number of negative appendectomies (surgical removal of non-inflamed appendix)	Within 30 days from randomization
Primary	Complicated appendicitis	Number of patients with complicated appendicitis (AAST grade 3 or higher)	Within 30 days from randomization
Secondary	histologically proven appendicitis	Number of patients with histologically proven appendicitis undergoing surgery	Within 30 days from randomization
Secondary	CT scan	Number of patients having abdominal computed tomography	Within 30 days from randomization
Secondary	Adverse events	Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)	Within one year from randomization
Secondary	Appendicitis	Number of patients diagnosed with appendicitis	Within 2 years from randomization
Secondary	Quality of life (EQ-5D-5L index value)	Quality of life determined by weekly EQ-5D-5L index values.	During the first 30 days from randomization
Secondary	Quality of life (EQ-5D-5L EQ-VAS score)	Quality of life determined by weekly EQ-5D-5L EQ-VAS score.	During the first 30 days from randomization
Secondary	Costs in Euros	Overall costs of diagnostics and treatment	During the first 30 days from randomization