Grey Zone Appendicitis: Role of Blood Test Biomarkers to Detect Early Appendicitis and to Decrease the Incidence of Negative Appendectomy

NCT04271826 | Completed

• 1 other identifier: zagu
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: many investigations emerged in the last decades and contribute towards a diagnosis of unsure appendicitis; they are valuable to the emergency general surgeon. Aim: This study aims to assess the role of laboratory markers (bilirubin and phospholipase A2) individually or combined with Computed Tomography (CT) for the diagnosis of grey zone appendicitis (Alvarado score 5-6). Methods: This prospective study included all 310 patients admitted with right iliac fossa (RIF) pain who had Alvarado score 5-6 (intermediate risk of appendicitis). All underwent full laboratory investigations including serum total bilirubin and phospholipase A2. All are underwent CT scan and classified into group A with normal CT but with persistent right iliac fossa pain and group B with proved acute appendicitis by CT. All cases underwent a laparoscopic or open appendectomy. Other causes of hyperbilirubine¬mia are excluded among the patients.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (2)

• serum bilirubin level

  role of blood biomarker in detecting acute appendicitis

  1 year

• phospholipase A2 level

  role of blood biomarker in detecting acute appendicitis

  1 year

Study Arms (2)

cases with normal CT

EXPERIMENTAL

evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis

Procedure: laparoscopic appendectomy

cases with proven appendicitis on CT

EXPERIMENTAL

evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis

Procedure: laparoscopic appendectomy

Interventions

laparoscopic appendectomy PROCEDURE

cases with normal CT underwent laparoscopic appendectomy

cases with normal CT; cases with proven appendicitis on CT

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: more than 14years of both sexes.
• Non pregnant female.
• Patients taking analgesics. .Patients who diagnosed to have grey zone diagnosis of acute appendicitis (Alvarado score 5-6).

You may not qualify if:

• Alvarado score \>6 or \< 5.
• Cases of sure acute appendicitis.
• Documented Liver disease, biliary disease (congenital or acquired), hemolytic diseases and history of alcoholism.
• \) Cases revealed other pathology than appendicitis by CT and laparoscopy.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 1234, Egypt

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• tamer A. alnaimy, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 17, 2020
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)