Diagnostic Algorithm for Appendizitis (DIALAPP)

NCT ID: NCT02627781

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-05-31

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.

Conditions

Reduction of Negative Appendectomy Rate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

suspected appendicitis

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Juliane Liese

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliane Liese, MD

Role: PRINCIPAL_INVESTIGATOR

General and Visceral Surgery

Locations

Goethe University

Frankfurt, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Juliane Liese, MD

Role: CONTACT

juliane.liese@kgu.de

+496963015251

Alexander Reinisch, MD

Role: CONTACT

alexander.reinisch@kgu.de

+4963016502

Facility Contacts

Juliane Liese, MD

Role: primary

juliane.liese@kgu.de

+4963015251

Alexander Reinisch, MD

Role: backup

alexander.reinisch@kgu.de

+4963016502

References

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.

Reference Type: DERIVED

PMID: 33210209 (View on PubMed)

Other Identifiers

268/15

Identifier Type: -

Identifier Source: org_study_id