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

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic appendectomy
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 < 5.
  • 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.

Sites / Locations

  • Tamer Alsaied Alnaimy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

cases with normal CT

cases with proven appendicitis on CT

Arm Description

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

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

Outcomes

Primary Outcome Measures

serum bilirubin level
role of blood biomarker in detecting acute appendicitis
phospholipase A2 level
role of blood biomarker in detecting acute appendicitis

Secondary Outcome Measures

Full Information

First Posted
February 9, 2020
Last Updated
February 14, 2020
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04271826
Brief Title
Grey Zone Appendicitis: Role of Blood Test Biomarkers to Detect Early Appendicitis and to Decrease the Incidence of Negative Appendectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. Bacteria invade the appendix and release tumour necrosis factor-alpha, Interleukien 6, and cytokines. These substances reach the liver through superior mesenteric vein and cause dysfunction of liver either by direct effect or indirectly through altering the hepatic blood flow. So it is important to evaluate the total bilirubin level in the diagnosis of clinically suspected cases of appendicitis (6) THE AIM OF THE WORK This study aims to evaluate the role of bilirubin and phospholipase A2 in: Cases of grey zone unsure appendicitis (intermediate risk Alvarado score 5-6). As a complementary to CT. Detect early cases of appendicitis. Decrease the incidence of negative appendicitis. Decrease complications of missed cases of appendicitis. Reduce the overnight appendectomy rate with its complications. Patients and methods Cases with normal CT but with persistent right iliac fossa tenderness and failed to improve under conservative treatment for 48 hrs With antibiotic therapy (Group A) underwent laparoscopic appendectomy. Patients proved to be appendicitis by CT underwent laparoscopic exploration (Group B). All the appendices removed were sent for histological examination and the operated cases divided into positive appendicitis (macroscopic or microscopic) and negative appendicitis. Group A , patients with normal CT but with persistent right iliac fossa pain. Group B , patients with proved acute appendicitis in CT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cases with normal CT
Arm Type
Experimental
Arm Description
evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis
Arm Title
cases with proven appendicitis on CT
Arm Type
Experimental
Arm Description
evaluate level of bilirubin and phospholipase A2 and their relation to positive or negative appendicitis
Intervention Type
Procedure
Intervention Name(s)
laparoscopic appendectomy
Intervention Description
cases with normal CT underwent laparoscopic appendectomy
Primary Outcome Measure Information:
Title
serum bilirubin level
Description
role of blood biomarker in detecting acute appendicitis
Time Frame
1 year
Title
phospholipase A2 level
Description
role of blood biomarker in detecting acute appendicitis
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 < 5. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tamer A. alnaimy, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tamer Alsaied Alnaimy
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
1234
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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