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临床试验/NCT04271826
NCT04271826已完成不适用

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

Zagazig University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
serum bilirubin level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
14 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • Alvarado score >6 or <
  • 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.

结局指标

主要结局

serum bilirubin level

时间窗: 1 year

role of blood biomarker in detecting acute appendicitis

phospholipase A2 level

时间窗: 1 year

role of blood biomarker in detecting acute appendicitis

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tamer Alsaied Alnaimy

assistant professour

Zagazig University

研究点 (2)

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