Optimizing the Diagnosis of Acute Appendicitis

NCT04117061 | Unknown DMC

• 1 other identifier: UADO-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Delta marker White blood cell count

  12 hours

• Delta marker CRP count

  12 hours

• Delta marker Alvarado acute appendicitis risk evaluation score

  12 hours

• Delta marker changes in ultrasound results

  12 hours

• 'Appendicitis Inflammatory Response (AIR) Score'

  12 hours

Study Arms (2)

Control

NO INTERVENTION

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

Observation

ACTIVE COMPARATOR

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

Interventions

Observation 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.

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant patient.
• 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.
• Clinical symptoms lasts for longer than 48 hours
• Signs of peritonitis

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

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

Vilnius, Lithuania

RECRUITING

MeSH Terms

Conditions

Appendicitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Tomas Poskus, Professor

  Vilnius University, Faculty of medicine, Institute of clinical medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Poskus, Professor.

CONTACT

+37068678893; tomas.poskus@santa.lt

Raminta Luksaite, Phd student

CONTACT

+37068960611; raminta.luksaite@santa.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor at Vilnius University

Model Details: Open, randomized, parallel groups prospective study

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: October 7, 2019
• Study Start: December 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)