Appendicitis Clinical Trial
— OPTICAPOfficial title:
The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis (OPTICAP)
NCT number | NCT02533869 |
Other study ID # | OPTICAP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | June 1, 2017 |
Verified date | November 2020 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 1, 2017 |
Est. primary completion date | June 1, 2017 |
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 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Negative appendectomy rate | Six months | ||
Secondary | Appendiceal perforation rate | Six months |
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