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Optimizing the Diagnosis of Acute Appendicitis (OPTIMA)

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ClinicalTrials.gov Identifier: NCT04117061
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Tomas Poskus, Vilnius University

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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Procedure: Observation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open, randomized, parallel groups prospective study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimizing the Diagnosis of Acute Appendicitis - Open, Randomized, Parallel Groups, Prospective Clinical Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Reduction of the CT scans number [ Time Frame: 24 hours ]
    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.

  2. Negative appendectomy rate [ Time Frame: 30 days ]
    We expect the negative appendectomy rate will will not increase while using alternative diagnostic protocol that includes patient observation.


Secondary Outcome Measures :
  1. Delta marker White blood cell count [ Time Frame: 12 hours ]
    The changes in white blood cell count over the time that might show higher or lower probability of possible acute appendicitis.

  2. Delta marker CRP count [ Time Frame: 12 hours ]
    The changes CRP level over the time that might show higher or lower probability of possible acute appendicitis.

  3. Delta marker Alvarado acute appendicitis risk evaluation score [ Time Frame: 12 hours ]
    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.

  4. Delta marker changes in ultrasound results [ Time Frame: 12 hours ]
    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.

  5. 'Appendicitis Inflammatory Response (AIR) Score' [ Time Frame: 12 hours ]
    '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..



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117061


Contacts
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Contact: Tomas Poskus, Professor. +37068678893 tomas.poskus@santa.lt
Contact: Raminta Luksaite, Phd student +37068960611 raminta.luksaite@santa.lt

Locations
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Lithuania
Faculty of medicine, Institue of clinical medicine, Clinic of gastroenterology, nephrourology and surgery Recruiting
Vilnius, Lithuania
Contact: Tomas Poskus, Professor    +37068678893    tomas.poskus@santa.lt   
Sponsors and Collaborators
Vilnius University
Investigators
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Principal Investigator: Tomas Poskus, Professor Vilnius University, Faculty of medicine, Institute of clinical medicine

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Responsible Party: Tomas Poskus, Profesor at Vilnius University, Vilnius University
ClinicalTrials.gov Identifier: NCT04117061     History of Changes
Other Study ID Numbers: UADO-1
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no future intensions make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes