Plain English Summary
Background and study aims
Appendicitis is a painful swelling of the appendix, a finger-like pouch connected to the large intestine. The Alvarado score is a clinical scoring system used in the diagnosis of appendicitis. In our study we want to compare the sensitivity and specificity of the Alvarado score and the clinical judgement made by our doctors.
Who can participate?
Patients aged over 18 presenting at the outpatient ward of the Surgical Department of the University of Szeged with suspected acute appendicitis.
What does the study involve?
Participants undergo an ultrasound examination in our Radiology Department. They are then divided into two groups. The groups alternate between weeks A and B. In week A the decision for treatment is based on the Alvarado score: the patient is either sent home, stays in hospital for observation, or is operated on. In week B the decision for treatment is based on the clinical judgement of the chief surgeon.
What are the possible risks and benefits of participating?
There are no risks to the participants, as the chief surgeon has the right to overrule the treatment based on the Alvarado score in week A, if the surgeon thinks that it isnt reliable. These patients are excluded from the trial.
When is the study starting and how long is it expected to run for?
The study started in August 2011 and is expected to run for a year and a half, or until 250 patients have been recruited.
Who is funding the study?
Department of Surgery, University of Szeged, Hungary.
Who is the main contact?
Professor György Lázár
iroda@surg.szote.u-szeged.hu
Trial website
Contact information
Type
Scientific
Primary contact
Prof Lázár György
ORCID ID
Contact details
Pécsi u. 6.
Szeged
6720
Hungary
iroda@surg.szote.u-szeged.hu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SZ001
Study information
Scientific title
Alvarado score versus clinical judgement in the diagnosis of acute appendicitis: a prospective, randomized controlled trial
Acronym
Study hypothesis
Our aim is to investigate the value of Alvarado score system in comparison with conventional clinical judgement
Ethics approval
Ethics Committee of University of Szeged, ref: 49/B-180/2010 KK
Study design
Prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute appendicitis
Intervention
We are planning to recruit 125 patients into each group, until we recruit approximately 250 participants. In each group we take the patient's history, physical examination, body temperature (rectal-axillar), white blood cell level, US examination. We calculate the Alvarado point of recovery patient.
In group A the further therapy depends on this point (1-4 emission, 5-6 observation, 7-10 laparoscopic or open appendectomy).
In group B the leading surgeon decides the therapy of the patient without reference of the Alvarado point. After appendectomy we check the pathological finding, call back the patient one week after the operation, and one year after it to a control examination.
In case of emission without operation, we make a control one year after the appearance in our emergency room, to find out if the symptoms or complaints are still occurring.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Specificity, sensitivity and positive predictive value of Alvarado score vs clinical judgement.
Secondary outcome measures
Measure the specificity and sensitivty of US examination practice in our department
Overall trial start date
01/09/2011
Overall trial end date
01/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged 18 or older, who present in our Surgical Department with right quadrant abdominal pain are included in our study
2. Every participiant should be able to read through an information sheet and sign a consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Does not meet inclusion criteria
2. Those who refuse the participation in our study
Recruitment start date
01/09/2011
Recruitment end date
01/09/2012
Locations
Countries of recruitment
Hungary
Trial participating centre
Pécsi u. 6.
Szeged
6720
Hungary
Sponsor information
Organisation
University of Szeged (Hungary)
Sponsor details
Department of Surgery
Pécsi u. 6.
Szeged
6720
Hungary
+36 (0)62 545 462
iroda@surg.szote.u-szeged.hu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Research Foundation of the University of Szeged (Hungary) - Department of Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary