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

NCT05093660 | Unknown

• 1 other identifier: 2181-147/01/06/M.S.-20-02
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute

Outcome Measures

Primary Outcomes (2)

• Level of LGR1 protein in blood

  Levels of LGR1 protein in blood and saliva as measured by ELISA test

  72 hours

• Level of LGR1 protein saliva

  Levels of LGR1 protein in saliva as measured by ELISA test

  72 hours

Study Arms (2)

Patients with acute appendicitis

Patients with acute appendicitis, after surgery and with pathohistological specimen confirmation.

Diagnostic Test: Blood specimen collection; Diagnostic Test: Saliva specimen collection

Patients without acute appendicitis

Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance.

Diagnostic Test: Blood specimen collection; Diagnostic Test: Saliva specimen collection

Interventions

Blood specimen collection DIAGNOSTIC_TEST

Blood specimen collection for analysis of CRP (C-reactive protein), WBC (White blood cells) and LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels

Patients with acute appendicitis; Patients without acute appendicitis

Saliva specimen collection DIAGNOSTIC_TEST

Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels

Patients with acute appendicitis; Patients without acute appendicitis

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 5 to 17 years of age, presenting with acute abdominal pain consistent with diagnosis of acute appendicitis, to Emergency Surgery Department at the University Hospital Split.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KBC Split: lead

Study Sites (1)

University Hospital Split

Split, Split-Dalmatia County, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Appendicitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Goran Tintor, MD

CONTACT

+38521557111; gogitintor@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic surgery resident

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 26, 2021
• Study Start: October 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)