Condition category
Digestive System
Date applied
13/07/2011
Date assigned
19/09/2011
Last edited
05/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 isn’t 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

http://www.u-szeged.hu/english/

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

Publication citations

Additional files

Editorial Notes