Clinical trial NCT04117061: Optimizing the Diagnosis of Acute Appendicitis
Official title: Optimizing the Diagnosis of Acute Appendicitis - Open, Randomized, Parallel Groups, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Appendicitis
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, randomized, parallel groups prospective study
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient with the symptoms of acute appendicitis: pain in the right lower quadrant, pain migration from epigastrium to right lower quadrant, nausea, rebound pain, elevated temperature.

Exclusion Criteria for randomized part:

* Pregnant patient.

Inclusion Criteria for randomized part:

* After primary clinical, laboratory and ultrasound examination diagnosis of acute appendicitis could not be confirmed or excluded.
* No other gynecological, urological ir gastroenterological pathology is confirmed.

Exclusion Criteria for randomized part:

* Clinical symptoms lasts for longer than 48 hours
* Signs of peritonitis

Primary outcomes:
measure: Reduction of the CT scans number
timeFrame: 24 hours
measure: Negative appendectomy rate
timeFrame: 30 days
Secondary outcomes:
measure: Delta marker White blood cell count
timeFrame: 12 hours
measure: Delta marker CRP count
timeFrame: 12 hours
measure: Delta marker Alvarado acute appendicitis risk evaluation score
timeFrame: 12 hours
measure: Delta marker changes in ultrasound results
timeFrame: 12 hours
measure: 'Appendicitis Inflammatory Response (AIR) Score'
timeFrame: 12 hours
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Faculty of medicine, Institue of clinical medicine, Clinic of gastroenterology, nephrourology and surgery
Study officials:
affiliation: Vilnius University, Faculty of medicine, Institute of clinical medicine
name: Tomas Poskus, Professor
role: PRINCIPAL_INVESTIGATOR
References: