Grey Zone Appendicitis (Intermediate Risk Alvarado Score 5-6): Role of Blood Test Biomarkers to Detect Early Appendicitis and to Decrease the Incidence of Negative Appendectomy: Cost and Effectiveness: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- serum bilirubin level
Study Overview
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.
Detailed Description
INTRODUCTION Acute appendicitis is a very common surgical emergency worldwide, with a lifetime risk reported to be 7-8%..Accordingly, appendectomy is the most frequently performed operation worldwide.
Many surgical centers attempt to reduce surgical procedures performed during the night, and delaying appendectomy for 12-24 h does not seem to increase complications
Despite thorough research, the diagnosis of acute appendicitis is still difficult and remains the most common problem in clinical surgery.
In addition to clinical examination of the patients with appendicitis, ultrasonography and multidetector computed tomography (MDCT) have become the most useful tools with a respective sensitivity and specificity of 98.5% and 98.0% in expert centers Routine use of MDCT not only increases exposure to radiation but also very expensive and time-consuming. Thus evolving methods to diagnose early acute appendicitis without radiological examinations are of interest.
Observing serum bilirubin and phospholipase A2 level came into consideration as it seems to elevate in early appendicitis, its determination is fast and can be performed with other commonly performed blood tests.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 14 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •Alvarado score >6 or <
- •Cases of sure acute appendicitis.
- •Documented Liver disease, biliary disease (congenital or acquired), hemolytic diseases and history of alcoholism.
- •4) Cases revealed other pathology than appendicitis by CT and laparoscopy.
Arms & Interventions
cases with normal CT
evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis
Intervention: laparoscopic appendectomy (Procedure)
cases with proven appendicitis on CT
evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis
Intervention: laparoscopic appendectomy (Procedure)
Outcomes
Primary Outcomes
serum bilirubin level
Time Frame: 1 year
role of blood biomarker in detecting acute appendicitis
phospholipase A2 level
Time Frame: 1 year
role of blood biomarker in detecting acute appendicitis
Secondary Outcomes
No secondary outcomes reported
Investigators
Tamer Alsaied Alnaimy
assistant professour
Zagazig University