The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis (OPTICAP)

The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis (OPTICAP)

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Intra-abdominal Infection; Acute Disease; Appendicitis; Other and Unspecified Acute Appendicitis
• Intervention / Treatment: Radiation: Low-dose CT; Procedure: Laparoscopic appendectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-60 years
• Clinical suspicion of acute uncomplicated appendicitis based on history, physical examination, laboratory findings evaluated by a senior surgeon

Exclusion Criteria:

• Age <18 years or > 60 years
• Pregnancy or breastfeeding
• Allergy to contrast material or iodine
• History of appendectomy
• Renal failure, creatinine-value greater than the upper reference value
• Diabetes mellitus and metformin medication
• Suspicion of peritonitis and appendiceal perforation
• Incapability to cooperate and give consent to participate in the study
• A severe generalized disease or condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose CT for acute appendicitis; Low-dose computed tomography for diagnosing acute uncomplicated appendicitis Laparoscopic appendectomy	Radiation: Low-dose CT; Low-dose computed tomography for suspected acute uncomplicated appendicitis; Procedure: Laparoscopic appendectomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The specificity and sensitivity of low-dose CT in diagnosing acute uncomplicated appendicitis	The sensitivity and specificity will be evaluated based on the operative and histopathological findings after laparoscopic appendectomy	Four months

Secondary Outcome Measures

Outcome Measure	Time Frame
Negative appendectomy rate	Six months
Appendiceal perforation rate	Six months

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Paulina Salminen, MD, PhD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: low-dose computed tomography
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Gastrointestinal Diseases; Digestive System Diseases; Acute Disease; Appendicitis
• Other Study ID Numbers: OPTICAP