Optimizing the Diagnosis of Acute Appendicitis (OPTIMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04117061|
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Appendicitis||Procedure: Observation||Not Applicable|
This study consists of two parts:
- In the first part investigators enroll all patients (except pregnant) that are refered to Vilnius University Hospital Santaros clinics with suspected acute appendicitis in order to get cohort data. All patient get primary clinical evaluation, laboratory tests (WBC, CRP) an ultrasound examination.
- After primary evaluation if final diagnosis could not be made, and investigator still suspect acute appendicitis, participant is included in to randomised study part.
- Randomised sudy part has two arms: control and observation groups.
- Control group get the traditional diagnostic path - is refered to CT scan examination.
- Observation group get repeated evaluation after 8-12 hours and only than is diagnosis stays unclear, patient gets a CT scan.
- All patient are contacted after 30 days after visit to our hospital, to get information about their health status and possible additional visits to other hospitals or operations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open, randomized, parallel groups prospective study|
|Masking:||None (Open Label)|
|Official Title:||Optimizing the Diagnosis of Acute Appendicitis - Open, Randomized, Parallel Groups, Prospective Clinical Trial|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
No Intervention: Control
Patient gets usual diagnostic path: after inconclusive ultrasound is refered to CT scan.
Active Comparator: Observation
Patient after inconclusive primary evaluation is observed in emergency room for 8-12 hours and after the clinical evaluation, laboratory results and ultrasound examination is repeated.
Patient after primary investigation is observed for 8-12 hours, (instead of being send directly to CT scan), after observation repeated clinical evaluation, laboratory tests and ultrasound examination are done , if final diagnosis stays unclear the patient is refered to CT scan.
- Reduction of the CT scans number [ Time Frame: 24 hours ]when performing alternative diagnostic protocol, that includes patient observation for short period we expect to reduce a number of CT scans performed, for the patients with suspected acute appendicitis.
- Negative appendectomy rate [ Time Frame: 30 days ]We expect the negative appendectomy rate will will not increase while using alternative diagnostic protocol that includes patient observation.
- Delta marker White blood cell count [ Time Frame: 12 hours ]The changes in white blood cell count over the time that might show higher or lower probability of possible acute appendicitis.
- Delta marker CRP count [ Time Frame: 12 hours ]The changes CRP level over the time that might show higher or lower probability of possible acute appendicitis.
- Delta marker Alvarado acute appendicitis risk evaluation score [ Time Frame: 12 hours ]Delta marker Alvarado acute appendicitis risk evaluation score Tha changes in score over the time that might show higher or lower probability of possible acute appendicitis. Scale ranges decribe a prediction of having acute appendicitis: 1-4 33 % of having appendicitis, 5-6 66 % of hanving, 7-10 93 % of having appendicitis.
- Delta marker changes in ultrasound results [ Time Frame: 12 hours ]The changes in ultrasound findings over the time may progress and influence investigator to change opinion about the concusion. Repeated ultrasound diagnosis might change from unequivocal to acute apendicitis (and CT scan can be avoided then). We do use structured conclusions of the ultrasound exam, that might be: accute appendicitis; apendix visualised but changes are equivocal; apendix visualised uninflamed; apendix not visualised, but there are secondary findings; apendix not visualised and there is no secondary findings. We are going to measure the change in final ultrasound diagnosis over the time.
- 'Appendicitis Inflammatory Response (AIR) Score' [ Time Frame: 12 hours ]'Appendicitis Inflammatory Response (AIR) Score') evaluates the risk for acute appendicitis. scale ranges are: 0-4 low probability outpatient follow up, 5-8 inermediate probability in hospital observation, 9-12 high probability, surgical treatment..
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117061
|Contact: Tomas Poskus, Professor.||+email@example.com|
|Contact: Raminta Luksaite, Phd firstname.lastname@example.org|
|Faculty of medicine, Institue of clinical medicine, Clinic of gastroenterology, nephrourology and surgery||Recruiting|
|Contact: Tomas Poskus, Professor +37068678893 email@example.com|
|Principal Investigator:||Tomas Poskus, Professor||Vilnius University, Faculty of medicine, Institute of clinical medicine|