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Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis

NCT04207645 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2021-03-23

No results posted yet for this study

Summary

Purpose: The diagnostic approach of patients with acute appendicitis (AA) remains debated. A number of clinical prediction rules (CPRs) exist for diagnosis of AA with variable sensitivity, specificity, and diagnostic accuracy, in different ethnic populations. Among these, the Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA) score was shown to have a high sensitivity though with a poor specificity. The aim of this study is to modify and validate the RIPASA score in 4 distinct ethnic groups, and to compare the performance of the new score to the original RIPASA and Alvarado scores.

Methods: This multicenter, international prospective observational study will be conducted in 6 countries, and will include all eligible patients referred to surgical specialists with acute right iliac fossa pain or suspected AA in the participating centres. Patients will be categorized into 4 ethnic groups based on the country of origin. The modified RIPASA score will be developed in one ethnic group, and along with the original RIPASA and Alvarado scores, will be externally validated in the other 3 ethnic groups. Management of patients will be prospectively evaluated in a standardized manner. The focus of the analysis will be on the performance of the 3 CPRs in different ethnic and gender groups using receiver operating characteristic curve analyses.

Discussion: We expect this study to develop a CPR that can assist surgeons and surgical residents to early identify patients with AA in the busy clinical and low-resource settings, and to optimize the diagnostic value of the RIPASA and Alvarado scores in different ethnic and gender groups.

Conditions

  • Acute Appendicitis

Interventions

DIAGNOSTIC_TEST

Modified RIPASA score

Clinical Prediction Rules consist of clinical and laboratory parameters to aid diagnosis of acute appendicitis

Sponsors & Collaborators

  • Soba University Hospital

    lead OTHER

Principal Investigators

  • Hytham KS Hamid, MRCSEd · Soba University Hospital

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • India
  • Mexico
  • Nigeria
  • Pakistan
  • Spain
  • Sudan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207645 on ClinicalTrials.gov