Sensitivity and Specificity of the Alvarado Score for the Timely Differential Diagnosis of Acute Appendicitis in Samoa
NCT ID: NCT05168410
Last Updated: 2021-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
225 participants
OBSERVATIONAL
2015-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Design and Data Collection
A retrospective study design was used to evaluate all AA cases seen by the Surgical Department of TTM Hospital over the 24-month period between 1 January 2015 and 31 December 2016. The clinical medical records were obtained from the National Health Service PATIS System, using the search terms 'appendicitis', 'acute appendicitis', and 'appendicectomy'. A total of 289 records were retrieved. Thirty four (34) records were excluded having met the exclusion criteria: (1) final diagnosis was not AA (i.e., ectopic pregnancy, tubal ovarian abscess, other gynaecological pathologies, diverticulitis, Merkel diverticulitis, perforated ulcer), and (2) appendiceal abscess and/or appendiceal mass. Thirty (30) clinical records with missing data, and these were also excluded from the study. The final number of included for analysis was 225 cases. All 225 cases were initially treated with intravenous antibiotics upon presentation to the emergency department as per the National Health Service antibiotic guidelines: intravenous ceftriaxone and metronidazole was the first line of treatment, and alternative antibiotics were administered if unavailable (i.e., clindamycin + gentamycin or ampicillin, or gentamycin + metronidazole).
A purpose-designed data collection form and excel spreadsheet were created for the study. The following information was extracted from the clinical records: patient gender (male/female), age (years), address (urban/rural), time of admission (Morning/Afternoon/Night Shift), use of traditional/alternative medicine prior to attending emergency department (yes/no), administration of antibiotics by emergency department staff (yes/no), Alvarado Score (1-10), Ultrasound Scan for AA (Positive/negative/Inconclusive/Not performed), management of AA (appendicectomy/antibiotic therapy), intra-operative macroscopic examination (Grade 1-5), histopathology result for AA (Positive/Negative/Inconclusive/Not available), length of stay in hospital (days), and mortality (yes/no).
Data analysis The data was analysed using the SPSS (Version 2.1) statistical software package. Descriptive analysis was performed, and the chi-square test of significance was used to investigate for statistically significant differences between variables (significant at p\<0.05). The sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) were calculated for the Alvarado Score in identifying AA as confirmed by histopathology.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alvarado Score
The Alvarado Score assesses patient symptoms to enable optimal triage and management of cases with suspected acute appendicitis.a
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Final diagnosis was appendiceal abscess and/or appendiceal mass.
* Clinical records with missing data
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fiji National University
OTHER
Dr Annette Kaspar
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Annette Kaspar
Head of Audiology
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
s994956
Identifier Type: -
Identifier Source: org_study_id