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

Not Applicable

Recruiting

• Conditions: Appendicitis

• Registration Number: NCT06083064
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-13
• Study Start: 2023-11-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complicated appendicitis	Within 30 days from randomization	Number of patients with complicated appendicitis (AAST grade 3 or higher)
Negative appendectomy	Within 30 days from randomization	Number of negative appendectomies (surgical removal of non-inflamed appendix)

Secondary Outcome Measures

Name	Time	Method
Quality of life (EQ-5D-5L EQ-VAS score)	During the first 30 days from randomization	Quality of life determined by weekly EQ-5D-5L EQ-VAS score.
histologically proven appendicitis	Within 30 days from randomization	Number of patients with histologically proven appendicitis undergoing surgery
CT scan	Within 30 days from randomization	Number of patients having abdominal computed tomography
Appendicitis	Within 2 years from randomization	Number of patients diagnosed with appendicitis
Costs in Euros	During the first 30 days from randomization	Overall costs of diagnostics and treatment
Adverse events	Within one year from randomization	Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)
Quality of life (EQ-5D-5L index value)	During the first 30 days from randomization	Quality of life determined by weekly EQ-5D-5L index values.

Trial Locations

Locations (3)

HUS, Jorvi Hospital; 🇫🇮 Espoo, Finland

HUS, Meilahti Hospital; 🇫🇮 Helsinki, Finland

HUS, Hyvinkää Hospital; 🇫🇮 Hyvinkää, Finland