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

Not Applicable

Recruiting

• Conditions: Appendicitis
• Interventions: Diagnostic Test: Abdominal imaging; Other: Score based selective abdominal imaging; Other: Score based selective observation combined with selective abdominal imaging

• 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

Arm && Interventions

Group	Intervention	Description
Routine imaging	Abdominal imaging	Patients will have first abdominal ultrasound, and if findings are negative or inconclusive for appendicitis abdominal CT scan is made. If ultrasound is not available, CT scan can be the first imaging study. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Other patients are discharged or treated according to possible alternative diagnosis.
Adult Appendicitis Score based selective imaging	Score based selective abdominal imaging	Adult Appendicitis Score (AAS) is calculated as soon as possible. Patients with AAS 16 or higher are scheduled for urgent laparoscopic appendectomy. Patients with AAS 11- 15 will have abdominal imaging as in the group 1. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Patients with AAS 10 or less are discharged without imaging studies.
Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score	Score based selective observation combined with selective abdominal imaging	Patients with Adult Appendicitis Score (AAS) 10 or less are discharged without imaging studies. Patients with AAS 11 or more are managed based on Appendicitis Severity Score (ASS). ASS is used to identify patients with low risk of complicated disease. Patients with high ASS (\>4) are managed as patients in arm 2. Patients with low ASS (\<=4) begin observation protocol where patients can leave hospital and they are re-evaluated with repeated scoring after 12-24 hours from randomization. After re-scoring patients may be discharged if AAS is below 16 and decreasing and ASS is below 5 or if AAS is below 11. If AAS is 16 or higher or increasing, patients are scheduled for urgent laparoscopic appendectomy. After observation period, patients with decreasing AAS between 11-15 and ASS higher than 4 or patients with stable AAS between 11-15 are send for imaging study.

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, Hyvinkää Hospital; 🇫🇮 Hyvinkää, Finland

HUS, Meilahti Hospital; 🇫🇮 Helsinki, Finland