Clinical trial NCT05168410: Sensitivity and Specificity of the Alvarado Score for the Timely Differential Diagnosis of Acute Appendicitis in Samoa
Official title: Sensitivity and Specificity of the Alvarado Score for the Timely Differential Diagnosis of Acute Appendicitis in Samoa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: Alvarado Score
Lead sponsor: Tupua Tamasese Meaole Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Fiji National University
First posted: 2021-12-23
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Acute Appendicitis cases seen by the Surgical Department of TTM Hospital over the 24-month period between 1 January 2015 and 31 December 2016.

The final number of included for analysis was 225 cases.

Brief summary: Retrospective clinical data review design of all patients admitted to the Tupua Tamasese Meaole Hospital Surgical Unit for AA from January 2015 to December 2016. Exclusion criteria were appendiceal abscess and/or mass, and final diagnosis 'not acute appendicitis'. Age, sex, village, Alvarado Score, Ultrasound Scan Result, surgical management, and histopathology result were the main variables entered into the SPSS statistical software package for analysis.

Detailed description: METHODS

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.

Eligibility criteria: Inclusion Criteria:

• All Acute Appendicitis (AA) cases seen by the Surgical Department of TTM Hospital over the 24-month period between 1 January 2015 and 31 December 2016.

Exclusion Criteria:

* Final diagnosis was not Acute Appendicitis (i.e., ectopic pregnancy, tubal ovarian abscess, other gynaecological pathologies, diverticulitis, Merkel diverticulitis, perforated ulcer)
* Final diagnosis was appendiceal abscess and/or appendiceal mass.
* Clinical records with missing data

Primary outcomes:
measure: Effectiveness of the Alvarado Score for the identification of acute appendicitis in Samoa
timeFrame: 24 months
Secondary outcomes:
measure: Accuracy of the Alvarado Score for the identification of acute appendicitis in Samoa
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: