Acute AppendicitisNCT05168410
Sensitivity and Specificity of the Alvarado Score for the Timely Differential Diagnosis of Acute Appendicitis in Samoa
An observational study of Acute Appendicitis, run by Dr Annette Kaspar.
Trial 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'. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Alvarado Score
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Acute Appendicitis
- Being tested
- Alvarado Score
- Keywords
- Alvarado Score
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alvarado ScoreOther
The Alvarado Score assesses patient symptoms to enable optimal triage and management of cases with suspected acute appendicitis.a
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Alvarado Score for the identification of acute appendicitis in Samoa
The sensitivity of the Alvarado Score will be calculated for correct diagnosis of acute appendicitis based on confirmed acute appendicitis by histopathology results
Measured: 24 months
Secondary outcomes (1)
Accuracy of the Alvarado Score for the identification of acute appendicitis in Samoa
The specificity of the Alvarado Score will be calculated for correct diagnosis of acute appendicitis based on confirmed cases of acute appendicitis by histopathology
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 225 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Dr Annette Kaspar
- Sponsor type
- Other government
- Collaborators
- Fiji National University
- Responsible party
- Sponsor-investigator, Dr Annette Kaspar, Tupua Tamasese Meaole Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168410
- Sponsor's protocol ID
- s994956
- Status last verified
- Dec 2021
- First submitted
- 14 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of the Alvarado Score for the Timely Differential Diagnosis of Acute Appendicitis in Samoa
- ClinicalTrials.gov ID
- NCT05168410
- Acronym / sponsor ID
- s994956
- Conditions
- Acute Appendicitis
- Keywords
- Alvarado Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Dr Annette KasparOther government
- Collaborators
- Fiji National University
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alvarado ScoreThe Alvarado Score assesses patient symptoms to enable optimal triage and management of cases with suspected acute appendicitis.a | Other | – |
Primary outcome
Effectiveness of the Alvarado Score for the identification of acute appendicitis in Samoa
Time frame: 24 months
The sensitivity of the Alvarado Score will be calculated for correct diagnosis of acute appendicitis based on confirmed acute appendicitis by histopathology results
1 secondary outcome
Accuracy of the Alvarado Score for the identification of acute appendicitis in Samoa
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
Related trials for Acute Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Dr Annette Kaspar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the Alvarado Score for the identification of acute appendicitis in Samoa (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.