Evaluation of Diagnostic Algorithm for Suspected Acute Appendicitis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Evaluation of the negative appendectomy rate
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •complete evaluation, examination and diagnostic pathways of the patients with suspected appendicitis in our University Hospital
Exclusion Criteria
- •appendectomy during other operations
Outcomes
Primary Outcomes
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 Outcomes
- The influence of computed tomography for the diagnosis of acute appendicitis(30 days)
- Evaluation of postoperative complications(6 months)
- Incidence of readmission to hospital(6 months)
Investigators
Dr. Juliane Liese
MD
Goethe University