Comparison of clinical judgement and Alvarado score in the diagnosis of acute appendicitis

ISRCTN	ISRCTN56471730
DOI	https://doi.org/10.1186/ISRCTN56471730
Secondary identifying numbers	SZ001

Submission date: 13/07/2011
Registration date: 19/09/2011
Last edited: 05/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Lázár György
Scientific

Pécsi u. 6.
Szeged
6720
Hungary

Email	iroda@surg.szote.u-szeged.hu

Study information

Study design	Prospective randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Alvarado score versus clinical judgement in the diagnosis of acute appendicitis: a prospective, randomized controlled trial
Study objectives	Our aim is to investigate the value of Alvarado score system in comparison with conventional clinical judgement
Ethics approval(s)	Ethics Committee of University of Szeged, ref: 49/B-180/2010 KK
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2011
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	250
Key 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
Key exclusion criteria	1. Does not meet inclusion criteria 2. Those who refuse the participation in our study
Date of first enrolment	01/09/2011
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

Hungary

Study participating centre

Pécsi u. 6.

Szeged
6720
Hungary

Sponsor information

University of Szeged (Hungary)
University/education

Department of Surgery
Pécsi u. 6.
Szeged
6720
Hungary

Phone	+36 (0)62 545 462
Email	iroda@surg.szote.u-szeged.hu
Website	http://www.u-szeged.hu/english/
"ROR"	https://ror.org/01pnej532

Funders

Funder type

University/education

Research Foundation of the University of Szeged (Hungary) - Department of Surgery

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan