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

Primary Purpose

Appendicitis, Other and Unspecified Acute Appendicitis, Acute Disease

Status
Completed
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

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

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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low-dose CT for acute appendicitis

Arm Description

Low-dose computed tomography for diagnosing acute uncomplicated appendicitis Laparoscopic appendectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Negative appendectomy rate
Appendiceal perforation rate

Full Information

First Posted
August 18, 2015
Last Updated
November 10, 2020
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02533869
Brief Title
The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis
Acronym
OPTICAP
Official Title
The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis (OPTICAP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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. 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.

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 Diseases, Intra-abdominal Infection
Keywords
low-dose computed tomography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Low-dose CT for acute appendicitis
Arm Type
Experimental
Arm Description
Low-dose computed tomography for diagnosing acute uncomplicated appendicitis Laparoscopic appendectomy
Intervention Type
Radiation
Intervention Name(s)
Low-dose CT
Intervention Description
Low-dose computed tomography for suspected acute uncomplicated appendicitis
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
The specificity and sensitivity of low-dose CT in diagnosing acute uncomplicated appendicitis
Description
The sensitivity and specificity will be evaluated based on the operative and histopathological findings after laparoscopic appendectomy
Time Frame
Four months
Secondary Outcome Measure Information:
Title
Negative appendectomy rate
Time Frame
Six months
Title
Appendiceal perforation rate
Time Frame
Six months

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 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
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
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

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

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