Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein in Acute Appendicitis in Pediatric Patients

• Conditions: Appendicitis Acute
• Interventions: Diagnostic Test: Blood specimen collection; Diagnostic Test: Saliva specimen collection

• Registration Number: NCT05093660
• Lead Sponsor: KBC Split

Brief Summary

Acute appendicitis is a common and potentially serious medical condition which can be difficult to diagnose, especially in pediatric patients. To help recognize patients with acute appendicitis, number of laboratory and radiological test are used. Previous research has shown that Circulating Human Leucine-rich α-2-glycoprotein (LGR1) in the blood can be elevated in pediatric patients with acute appendicitis. The aim of this research is to analyse whether LGR1 levels in saliva can be used as a less invasive diagnostic method in pediatric patients with suspected acute appendicitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-10-13
• Study Start: 2021-10-15
• Study First Posted: 2021-10-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• children with age from 5 do 17 with acute abdominal pain
• children with clinical signs of appendicitis

Exclusion Criteria

• previous diagnosis of chronic and/or malignant disease
• children which had previous abdominal surgery
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without acute appendicitis	Blood specimen collection	Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance.
Patients with acute appendicitis	Blood specimen collection	Patients with acute appendicitis, after surgery and with pathohistological specimen confirmation.
Patients without acute appendicitis	Saliva specimen collection	Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance.
Patients with acute appendicitis	Saliva specimen collection	Patients with acute appendicitis, after surgery and with pathohistological specimen confirmation.

Primary Outcome Measures

Name	Time	Method
Level of LGR1 protein in blood	72 hours	Levels of LGR1 protein in blood and saliva as measured by ELISA test
Level of LGR1 protein saliva	72 hours	Levels of LGR1 protein in saliva as measured by ELISA test

Trial Locations

Locations (1)

University Hospital Split; 🇭🇷 Split, Splitsko-dalmatinska, Croatia