Diagnostic Algorithm for Appendizitis (DIALAPP) (DIALAPP)

Evaluation of Diagnostic Algorithm for Suspected Acute Appendicitis

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Juliane Liese, MD; Phone Number: +496963015251; Email: juliane.liese@kgu.de
• Study Contact Backup: Name: Alexander Reinisch, MD; Phone Number: +4963016502; Email: alexander.reinisch@kgu.de

Study Locations

• Germany
  • Frankfurt, Germany, 60590
    • Recruiting
    • Goethe University
    • Contact: Alexander Reinisch, MD; Phone Number: +4963016502; Email: alexander.reinisch@kgu.de
    • Contact: Juliane Liese, MD; Phone Number: +4963015251; Email: juliane.liese@kgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to our University department with suspected appendicitis and/or lower right abdominal pain.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Goethe University
• Investigators: Principal Investigator: Juliane Liese, MD, General and Visceral Surgery

Publications and helpful links

General Publications

• Malkomes P, Edmaier F, Liese J, Reinisch-Liese A, El Youzouri H, Schreckenbach T, Bucher AM, Bechstein WO, Schnitzbauer AA. DIALAPP: a prospective validation of a new diagnostic algorithm for acute appendicitis. Langenbecks Arch Surg. 2021 Feb;406(1):141-152. doi: 10.1007/s00423-020-02022-7. Epub 2020 Nov 19.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: acute appendicitis; Alvarado Score; negative appendectomy; right abdominal pain
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: 268/15