NCT04117061

Optimizing the Diagnosis of Acute Appendicitis

Optimizing the Diagnosis of Acute Appendicitis - Open, Randomized, Parallel Groups, Prospective Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Vilnius University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Observation	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.

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-01-01
• Completion: 2021-05-01
• First posted: 2019-10-07
• Last updated: 2019-10-07

Locations

1 site across 1 country: Lithuania