Diagnostic Algorithm for Appendizitis (DIALAPP)

Reduction of Negative Appendectomy Rate Clinical Trial

— DIALAPP  

Official title:

Evaluation of Diagnostic Algorithm for Suspected Acute Appendicitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627781
• Other study ID #: 268/15
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2015
• Last updated: August 31, 2016
• Start date: November 2015
• Est. completion date: May 2018

Study information

• Verified date: August 2016
• Source: Goethe University
• Contact: Juliane Liese, MD
• Phone: +496963015251
• Email: juliane.liese[@]kgu.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• appendectomy during other operations

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Appendicitis
• Reduction of Negative Appendectomy Rate

Locations

Country	Name	City	State
Germany	Goethe University	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the negative appendectomy rate	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.	6 months	No
Secondary	The influence of computed tomography for the diagnosis of acute appendicitis	In this part of the study the investigators evaluate the careful and cost-effective integration of computed tomography in the clinical pathway.	30 days	No
Secondary	Incidence of readmission to hospital	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.	6 months	No
Secondary	Evaluation of postoperative complications	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.	6 months	No