The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI >30 (OPTICAP>30)

The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI Over 30 kg/m2 (OPTICAP BMI >30)

This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to differentiate between uncomplicated and complicated acute appendicitis. Accurate differential diagnosis allows the assessment of all available treatment options. Complicated acute appendicitis requires emergency appendectomy, while uncomplicated acute appendicitis can be safely and efficiently treated with antibiotics in the majority of patients. Our study group already published the results of the initial OPTICAP trial enrolling patients with BMI under 30 showing similar accuracy between the low-dose and the stadard dose CT, but a significant dose reduction associated with the low-dose CT. All patients will undergo both imaging protocols as the standard CT is also optimized for a low as possible radiation dosage and imaging sequence per patient is randomized due to the optimization of contrast media injection timing. All patients participating in this study will be treated operatively with a laparoscopic appendectomy to obtain histological confirmation for the diagnosis to evaluate the accuracy of the CT imaging. The aim of this study is to optimize a well-performing low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis in patients with body mass index over 30 kg/m2.

Study Overview

• Status: Suspended
• Conditions: Intra-abdominal Infection; Acute Disease; Appendicitis; Gastrointestinal Disease; 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 gold standard and CT has been shown to clearly outperform US in terms of diagnostic performance. Currently 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 in patients with BMI over 30 kg/m2. Accurate differential diagnosis allows the assessment of all available treatment options. Complicated acute appendicitis requires emergency appendectomy, while uncomplicated acute appendicitis can be safely and efficiently treated with antibiotics in the majority of patients. Our study group already published the results of the initial OPTICAP trial enrolling patients with BMI under 30 showing similar accuracy between the low-dose and the stadard dose CT, but a significant dose reduction associated with the low-dose CT. All patients will undergo both imaging protocols as the standard CT is also optimized for a low as possible radiation dosage and imaging sequence per patient is randomized due to the optimization of contrast media injection timing. All patients participating in this study will be treated operatively with a laparoscopic appendectomy to obtain histological confirmation for the diagnosis to evaluate the accuracy of the CT imaging. The aim of this study is to optimize a well-performing low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis in patients with body mass index over 30 kg/m2.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20521
      • 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
• Body mass index over 30 kg/m2

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

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 in patients with BMI >30; Low-dose computed tomography (CT) vs. standard CT for diagnosing acute uncomplicated appendicitis in patients with BMI > 30 Laparoscopic appendectomy	Radiation: Low-dose CT; Low-dose computed tomography for suspected acute uncomplicated appendicitis in patients with BMI >30; Procedure: Laparoscopic appendectomy; All patients with BMI >30, who are 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 accuracy of low-dose vs. standard CT in diagnosing acute uncomplicated appendicitis in patients with BMI >30	CT accuracy between low-dose and standard CT will be evaluated based on the operative and histopathological findings after laparoscopic appendectomy	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Negative appendectomy rate	30 days
Appendiceal perforation rate	30 days
Sensitivity and specificity of the imaging protocols	30 days
Radiation dose	30 days

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 (Actual): November 4, 2020
• Primary Completion (Actual): November 17, 2021
• Study Completion (Anticipated): November 17, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: body mass index; low-dose computed tomography; BMI > 30
• 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 BMI >30kg/m2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Available from the study PI upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No