NCT04207645: MODRIS

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

Terminated Last updated 23 March 2021

What this trial tests

trial testing Modified RIPASA score in Acute Appendicitis in 240 participants. Terminated before completion.

Timeline

1 November 2019

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Soba University Hospital
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	240
Start date	1 November 2019
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	37 locations across Pakistan, Sudan, Mexico, Nigeria, Spain, India

Drugs / interventions tested

• Modified RIPASA score

Conditions studied

• Acute Appendicitis — all drugs for Acute Appendicitis →

Sponsor

Soba University Hospital

Who can join

16 and older, any sex, with Acute Appendicitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.