The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis
Condition: Appendicitis; Other and Unspecified Acute Appendicitis; Acute Disease; Gastrointestinal Diseases; Intra-abdominal Infection
MeSH terms: Appendicitis; Intraabdominal Infections; Gastrointestinal Diseases; Digestive System Diseases; Acute Disease
Study type: Interventional

Summary: 
      This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to
      differentiate between uncomplicated and complicated acute appendicitis. Differentiation
      between the two forms of acute appendicitis is important because according to recent studies
      their treatment differs. Complicated forms are still treated operatively, while uncomplicated
      forms can be treated conservatively with antibiotics. In the initial phase of the study,
      several optimized CT protocols will be created with a phantom model. The two best performing
      models will be selected for the second phase of the study, in which patients presenting with
      suspected acute appendicitis will be imaged with the two protocols. All patients
      participating in the study will be treated operatively, primarily with a laparoscopic
      appendectomy. Thus histological confirmation for the diagnosis can be achieved and compared
      with the CT images. The goal of this study is to optimize a well-performing low-dose CT
      imaging protocol to use in the diagnosis of uncomplicated acute appendicitis.
    

Detailed description: 
      Acute appendicitis is one of the most common causes of abdominal pain in emergency
      departments as well as one of the most common indications for emergency abdominal surgery.
      The clinical diagnosis has been based on patient history, physical examination and laboratory
      findings as well as the "clinical eye" of the surgeon. Still the diagnosis remains
      challenging. One of the main problems is that many other disorders can mimic the clinical
      presentation of appendicitis, thus increasing the role of imaging techniques to aid in
      diagnostic accuracy. Now preoperative imaging in patients with suspected acute appendicitis
      is currently widely accepted as the standard of practice, and CT has been shown to clearly
      outperform US in terms of diagnostic performance. Nowadays, CT imaging is considered the
      primary imaging modality in the diagnosis for acute appendicitis as it is appraised for its
      high sensitivity and specificity. The main disadvantage of CT imaging is exposure to
      radiation. Thus the favorable diagnostic performance of CT imaging has encouraged
      optimization of protocols to minimize exposure to radiation through the development of
      low-dose CT protocols. Initial studies have indicated that contrast enhanced low-dose CT was
      not inferior to standard-dose contrast enhanced CT with no statistical significance in
      negative appendectomy rates, appendiceal perforation rates or patients requiring additional
      imaging.

      This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to
      differentiate between uncomplicated and complicated acute appendicitis. Differentiation
      between the two forms of acute appendicitis is important because according to recent studies
      their treatment differs. Complicated forms are still treated operatively, while uncomplicated
      forms can be treated conservatively with antibiotics. In the initial phase of the study,
      several optimized CT protocols will be created with a phantom model. The two best performing
      models will be selected for the second phase of the study, in which patients presenting with
      suspected acute appendicitis will be imaged with the two protocols. All patients
      participating in the study will be treated operatively, primarily with a laparoscopic
      appendectomy. Thus histological confirmation for the diagnosis can be achieved and compared
      with the CT images. The goal of this study is to optimize a well-performing low-dose CT
      imaging protocol to use in the diagnosis of uncomplicated acute appendicitis.
    

Intervention name(s): Low-dose CT; Laparoscopic appendectomy
Intervention type(s): Radiation; Procedure
Intervention description(s): Low-dose computed tomography for suspected acute uncomplicated appendicitis; All patients diagnosed with an uncomplicated acute appendicitis on low-dose CT-scan will undergo laparoscopic appendectomy to evaluate the sensitivity and specificity of the CT diagnosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: low-dose computed tomography