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

Primary Purpose

Appendicitis, Other and Unspecified Acute Appendicitis, Acute Disease

Status
Suspended
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Low-dose CT
Laparoscopic appendectomy
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis focused on measuring low-dose computed tomography, body mass index, BMI > 30

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Turku University hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low-dose CT for acute appendicitis in patients with BMI >30

Arm Description

Low-dose computed tomography (CT) vs. standard CT for diagnosing acute uncomplicated appendicitis in patients with BMI > 30 Laparoscopic appendectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Negative appendectomy rate
Appendiceal perforation rate
Sensitivity and specificity of the imaging protocols
Radiation dose

Full Information

First Posted
August 17, 2020
Last Updated
February 8, 2022
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04519086
Brief Title
The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI >30
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Suspended
Why Stopped
CT imaging equipment was upgraded during trial enrollment. Old imaging protocols were no longer compatible with new generation CT. As these were not comparable to previous imaging, study was suspended for analysis and reporting of imaging so far.
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
November 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Other and Unspecified Acute Appendicitis, Acute Disease, Gastrointestinal Disease, Intra-abdominal Infection
Keywords
low-dose computed tomography, body mass index, BMI > 30

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose CT for acute appendicitis in patients with BMI >30
Arm Type
Experimental
Arm Description
Low-dose computed tomography (CT) vs. standard CT for diagnosing acute uncomplicated appendicitis in patients with BMI > 30 Laparoscopic appendectomy
Intervention Type
Radiation
Intervention Name(s)
Low-dose CT
Intervention Description
Low-dose computed tomography for suspected acute uncomplicated appendicitis in patients with BMI >30
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
The accuracy of low-dose vs. standard CT in diagnosing acute uncomplicated appendicitis in patients with BMI >30
Description
CT accuracy between low-dose and standard CT will be evaluated based on the operative and histopathological findings after laparoscopic appendectomy
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Negative appendectomy rate
Time Frame
30 days
Title
Appendiceal perforation rate
Time Frame
30 days
Title
Sensitivity and specificity of the imaging protocols
Time Frame
30 days
Title
Radiation dose
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Salminen, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University hospital
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Available from the study PI upon request.

Learn more about this trial

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

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