Optimizing the Diagnosis of Acute Appendicitis

NCT ID: NCT04117061

Last Updated: 2019-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-05-01

Brief Summary

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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.

Detailed Description

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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

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Acute Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open, randomized, parallel groups prospective study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control

Patient gets usual diagnostic path: after inconclusive ultrasound is refered to CT scan.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Observation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.


* 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

* Pregnant patient.


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Tomas Poskus

Profesor at Vilnius University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomas Poskus, Professor

Role: PRINCIPAL_INVESTIGATOR

Vilnius University, Faculty of medicine, Institute of clinical medicine

Locations

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Faculty of medicine, Institue of clinical medicine, Clinic of gastroenterology, nephrourology and surgery

Vilnius, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Tomas Poskus, Professor.

Role: CONTACT

+37068678893

Raminta Luksaite, Phd student

Role: CONTACT

+37068960611

Facility Contacts

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Tomas Poskus, Professor

Role: primary

+37068678893

Other Identifiers

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UADO-1

Identifier Type: -

Identifier Source: org_study_id

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