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Diagnostic Algorithm for Appendizitis (DIALAPP) (DIALAPP)

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ClinicalTrials.gov Identifier: NCT02627781
Recruitment Status : Unknown
Verified August 2016 by Dr. Juliane Liese, Goethe University.
Recruitment status was:  Recruiting
First Posted : December 11, 2015
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Juliane Liese, Goethe University

Study Description
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Brief Summary:

The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to negative appendectomies. The aim of the present observation study is to evaluate a diagnostic and therapeutic algorithm for suspected acute appendicitis.

The investigators believe that this diagnostic algorithm helps to simultaneously avoid unnecessary operations, costs and radiation exposure.


Condition or disease
Reduction of Negative Appendectomy Rate

Detailed Description:

This prospective observation study will be performed in the university hospital Frankfurt with a 24-h emergency service, with surgery and radiology readily available. The data will be compiled on patients older than 18 years who will be admitted to the emergency unit with suspected appendicitis.

During the study period, the clinical workflow is standardized. In all cases a resident of surgery and/or consultant surgeon clinically evaluate and perform an ultrasound scan on all patients with suspected appendicitis. With the use of clinical and laboratory results the physician (surgeon) will calculate the Alvarado Score and depending on the result the next diagnostic steps or the treatment will be chosen. Additionally, the department of gynecology of the university hospital routinely evaluate all women of childbearing age. Upon other terms following variables will be collected: age, gender, white blood cells (WBC), C-reactive protein (CRP), Alvarado Score, visuell pain scale, CT scan results, pathologic findings, time between admission and operation, operation procedure, treatment and diagnosis of patients without operation, length of hospital stay, and 30-day complication rate. Furthermore, there will be a follow-up of all patients (with and without operation) after 30 days and 6 months.

The investigators assume that the use of a diagnostic and therapeutic algorithm reduces unnecessary negative appendectomies and optimizes the duration of the hospital stay and the costs.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Evaluation of Diagnostic Algorithm for Suspected Acute Appendicitis
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Groups and Cohorts
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Group/Cohort
suspected appendicitis
This group includes all patients with suspected appendicitis, who are admitted to our University Hospital.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the negative appendectomy rate [ Time Frame: 6 months ]
    In this part of the study, the negative appendectomy rate will be determined. A negative appendectomy is characterized by normal findings in the pathological examination and therefore constitutes a medically unnecessary appendectomy.


Secondary Outcome Measures :
  1. The influence of computed tomography for the diagnosis of acute appendicitis [ Time Frame: 30 days ]
    In this part of the study the investigators evaluate the careful and cost-effective integration of computed tomography in the clinical pathway.

  2. Incidence of readmission to hospital [ Time Frame: 6 months ]
    In this part of the study the readmission rate to hospital will be evaluated because of postoperative complications, infections and continuous abdominal pain will be included.

  3. Evaluation of postoperative complications [ Time Frame: 6 months ]
    In all patients, who received an appendectomy the postoperative complication rate will be recorded. In statistical analysis factors, which are associated with complications will be analyzed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to our University department with suspected appendicitis and/or lower right abdominal pain.
Criteria

Inclusion Criteria:

  • complete evaluation, examination and diagnostic pathways of the patients with suspected appendicitis in our University Hospital

Exclusion Criteria:

  • appendectomy during other operations
Contacts and Locations
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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): NCT02627781


Contacts
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Contact: Juliane Liese, MD +496963015251 juliane.liese@kgu.de
Contact: Alexander Reinisch, MD +4963016502 alexander.reinisch@kgu.de

Locations
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Germany
Goethe University Recruiting
Frankfurt, Germany, 60590
Contact: Juliane Liese, MD    +4963015251    juliane.liese@kgu.de   
Contact: Alexander Reinisch, MD    +4963016502    alexander.reinisch@kgu.de   
Sponsors and Collaborators
Goethe University
Investigators
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Principal Investigator: Juliane Liese, MD General and Visceral Surgery
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Juliane Liese, MD, Goethe University
ClinicalTrials.gov Identifier: NCT02627781    
Other Study ID Numbers: 268/15
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Keywords provided by Dr. Juliane Liese, Goethe University:
acute appendicitis
Alvarado Score
negative appendectomy
right abdominal pain
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases