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Aim of the study: to identify the signs of acute appendicitis delta signs - clinical, laboratory or ultrasound signs, whose change (delta) would allow to identify or deny the diagnosis of acute appendicitis without a computed tomography examination and thus to lower computed tomography rates.
This study consists of two parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patient gets usual diagnostic path: after inconclusive ultrasound is refered to CT scan. | |
| Observation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the CT scans number | 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. | 24 hours |
| Negative appendectomy rate | We expect the negative appendectomy rate will will not increase while using alternative diagnostic protocol that includes patient observation. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Delta marker White blood cell count | The changes in white blood cell count over the time that might show higher or lower probability of possible acute appendicitis. | 12 hours |
| Delta marker CRP count |
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Inclusion Criteria:
Exclusion Criteria for randomized part:
Inclusion Criteria for randomized part:
Exclusion Criteria for randomized part:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomas Poskus, Professor. | Contact | +37068678893 | tomas.poskus@santa.lt | |
| Raminta Luksaite, Phd student | Contact | +37068960611 | raminta.luksaite@santa.lt |
| Name | Affiliation | Role |
|---|---|---|
| Tomas Poskus, Professor | Vilnius University, Faculty of medicine, Institute of clinical medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Institue of clinical medicine, Clinic of gastroenterology, nephrourology and surgery | Recruiting | Vilnius | Lithuania |
There are no future intensions make IPD available.
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Open, randomized, parallel groups prospective study
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|
The changes CRP level over the time that might show higher or lower probability of possible acute appendicitis.
| 12 hours |
| Delta marker Alvarado acute appendicitis risk evaluation score | 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. | 12 hours |
| Delta marker changes in ultrasound results | 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. | 12 hours |
| 'Appendicitis Inflammatory Response (AIR) Score' | '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.. | 12 hours |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |