Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001043628
Ethics application status
Approved
Date submitted
14/09/2014
Date registered
26/09/2014
Date last updated
1/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between Modified Alvarado and Raja Isteri Pengiran Anak Saleha (RIPAS) Scores in the Diagnosis of Acute Appendicitis in Adults Among Population of Southern Region of Saudi Arabia.
Scientific title
Comparison between Modified Alvarado and Raja Isteri Pengiran Anak Saleha (RIPAS) Scores in the Diagnosis of Acute Appendicitis in Adults Among Population of Southern Region of Saudi Arabia in terms of accuracy of diagnosis.
Secondary ID [1] 285335 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Appendicitis 293062 0
Condition category
Condition code
Surgery 293333 293333 0 0
Other surgery
Oral and Gastrointestinal 293392 293392 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both modified Alvarado and RIPASA scores will be fulfilled by the research team for patients who are going to be operated for acute appendicitis in the preoperative period.

Modified Alvarado Score
Symptoms
Migration of pain to the right lower quadrant 1

Anorexia 1
Nausea/Vomiting 1
Signs
Tenderness in the right iliac fossa 2
Rebound tenderness in the right iliac fossa 1

Elevated temperature (>37,3 degrees Centigrade) 1
Investigations
Leukocytosis (>10.000/ml) 2
Total


RIPASA
Demographic data
Male 1.0
Female 0.5
Age < 39.9 years 1.0
Age greater than or equal 40 years 0.5
Symptoms
RIF pain 0.5
Migration of RQP 0.5
Anorexia 1.0
Nausea / Vomiting 1.0
Duration of Symptoms < 48 hrs 1.0
Duration of Symptoms > 48 hrs 0.5
Signs
RIF tenderness 1.0
RIF guarding 2.0
Rebound tenderness 1.0
Rovsing’s sign 2.0
Fever >37 - < 39 degrees Centigrade 1.0
Investigations
Raised WBCs 1.0
Negative Urinalysis 1.0
Additional scores
Foreign ID 1.0
Total

Both scores will be calculated for each patient by summation of the points of positive finding, then sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for both scoring systems will be calculated.
Intervention code [1] 290249 0
Diagnosis / Prognosis
Comparator / control treatment
Modified Alvarado and RIPASA Scores for diagnosing acute appendicitis. both scores are compared to operative findings and postoperative histopathology then sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for both scoring systems will be calculated.
Control group
Active

Outcomes
Primary outcome [1] 293164 0
Accuracy of diagnosing acute appendicitis
Timepoint [1] 293164 0
detected by the doctor by comparing the preoperative Modified Alvarado and RIPASA Scores with operative findings and postoperative histopathology
Secondary outcome [1] 310475 0
nil
Timepoint [1] 310475 0
nil

Eligibility
Key inclusion criteria
All patients older than 13 years who will undergo appendectomy will be included in the study.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients below 13 years are treated by the pediatric team according to the policy of our hospital and will be excluded from the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients older than 13 years who will undergo appendectomy will be included in the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated according to Dahiru et al to be 60 patients with Za=1.96, expected prevalence of correctly diagnosed cases of appendicitis is 85%, and accepted error of 0.09
Paired t test will be used to compare between both scores.,Chi-Square test was applied for qualitative data (Fisher exact test was used when appropriate). A statistically significant p-value was considered at p<0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
1/10/2014
Date of last participant enrolment
Anticipated
30/11/2014
Actual
3/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6353 0
Saudi Arabia
State/province [1] 6353 0
Asir/ Abha

Funding & Sponsors
Funding source category [1] 289951 0
Self funded/Unfunded
Name [1] 289951 0
Country [1] 289951 0
Primary sponsor type
University
Name
King Khalid University
Address
Greiger
Zip: 61421
P.O.: 641
Abha
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 288641 0
Hospital
Name [1] 288641 0
Aseer Central Hospital
Address [1] 288641 0
King Abdullah Road
PO Box 34
Zip: 62523
Abha
Saudi Arabia
Country [1] 288641 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294540 0
Ethical Committee of King Khalid University
Ethics committee address [1] 294540 0
Saudi Arabia
Abha
Greiger
King Khalid University, Building C
Ethical Committee
PO 641, Zip 61421
Ethics committee country [1] 294540 0
Saudi Arabia
Date submitted for ethics approval [1] 294540 0
06/06/2014
Approval date [1] 294540 0
30/11/2014
Ethics approval number [1] 294540 0
REC # 2014-06-06

Summary
Brief summary
Absolute diagnosis of acute appendicitis is only possible with histopathology results after appendectomy. On the other hand, the decision to perform surgery is based solely on clinical evaluation supplemented by laboratory data. Therefore diagnostic errors are common, resulting in a median incidence of perforation of 20% and a negative laparotomy rate ranging from 2% to 30%. So aim of our study is to compare Modified Alvarado score versus RIPASA score in diagnosing acute appendicitis among middle eastern population in Aseer region (southern region of Saudi Arabia).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 792 792 0 0
/AnzctrAttachments/367095-Ethical approval.pdf

Contacts
Principal investigator
Name 51438 0
A/Prof Walid Abd El Maksoud MD, MRCS
Address 51438 0
King Khalid University, Abha, Saudi Arabia
Faculty of Medicine
Department of General Surgery
Zip: 61421
P.O.: 641
Country 51438 0
Saudi Arabia
Phone 51438 0
+966543128555
Fax 51438 0
Email 51438 0
dr.waleedmaksoud@gmail.com
Contact person for public queries
Name 51439 0
A/Prof Walid Abd El Maksoud MD, MRCS
Address 51439 0
King Khalid University, Abha, Saudi Arabia
Faculty of Medicine
Department of General Surgery
Zip: 61421
P.O.: 641
Country 51439 0
Saudi Arabia
Phone 51439 0
+966543128555
Fax 51439 0
Email 51439 0
dr.waleedmaksoud@gmail.com
Contact person for scientific queries
Name 51440 0
A/Prof Walid Abd El Maksoud MD, MRCS
Address 51440 0
King Khalid University, Abha, Saudi Arabia
Faculty of Medicine
Department of General Surgery
Zip: 61421
P.O.: 641
Country 51440 0
Saudi Arabia
Phone 51440 0
+966543128555
Fax 51440 0
Email 51440 0
dr.waleedmaksoud@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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