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

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Appendicitis

Treatments: Other: Score based selective abdominal imaging; Diagnostic Test: Abdominal imaging; Other: Score based selective observation combined with selective abdominal imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06083064

HUS/74/2023

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

Routine imaging

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Abdominal imaging

Adult Appendicitis Score based selective imaging

Experimental group

Description:

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.

Treatment:

Other: Score based selective abdominal imaging

Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score

Experimental group

Description:

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.

Treatment:

Other: Score based selective observation combined with selective abdominal imaging