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

Appendicitis Clinical Trial

— OPTICAP>30  

Official title:

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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04519086
• Other study ID #: OPTICAP BMI >30kg/m2
• Status: Suspended
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: November 17, 2023

Study information

• Verified date: February 2022
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Appendicitis
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Intra-abdominal Infection
• Intraabdominal Infections
• Other and Unspecified Acute Appendicitis

Intervention

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

Locations

Country	Name	City	State
Finland	Turku University hospital	Turku	Varsinais-Suomi

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Negative appendectomy rate		30 days
Secondary	Appendiceal perforation rate		30 days
Secondary	Sensitivity and specificity of the imaging protocols		30 days
Secondary	Radiation dose		30 days