Optimizing the Diagnosis of Acute Appendicitis (OPTIMA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: Observation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomas Poskus, Professor.; Phone Number: +37068678893; Email: tomas.poskus@santa.lt
• Study Contact Backup: Name: Raminta Luksaite, Phd student; Phone Number: +37068960611; Email: raminta.luksaite@santa.lt

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Recruiting
    • Faculty of medicine, Institue of clinical medicine, Clinic of gastroenterology, nephrourology and surgery
    • Contact: Tomas Poskus, Professor; Phone Number: +37068678893; Email: tomas.poskus@santa.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Vilnius University
• Investigators: Principal Investigator: Tomas Poskus, Professor, Vilnius University, Faculty of medicine, Institute of clinical medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Acute Disease; Appendicitis
• Other Study ID Numbers: UADO-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no future intensions make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No