Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).
Brief Summary:
On September the 15th, 2015, Italian surgeons, radiologists and pathologists with a special interest and expertise in the diagnosis and management of Acute Appendicitis (AA), met up under the auspices of the Italian Society of Hospital Surgeons (ACOI) in Oristano (Italy) to constitute the ACTUAA collaborative working group. The main objectives of the working group are:
To create a working basis for analyzing the diagnostic features, treatment modalities and outcomes of interest of both the antibiotic-first approach and appendectomy for patients with uncomplicated AA.
To investigate the clinical, laboratory and radiologic modalities adopted for the diagnosis To determine the outcomes of patients treated with antibiotics or appendectomy in the short and long term periods.
To compare results according to the type of intervention. To stratify the risk of recurrence for patients treated with antibiotics according to clinical, laboratory and radiology findings.
To evaluate the sensibility and specificity of clinical and laboratory scores for the diagnosis of uncomplicated AA.
To identify a subgroup of patients with uncomplicated AA for whom antibiotic treatment can be highly effective.
General study design The study protocol is designed according to the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials".
The study period is estimated to be of 12 month + 12 month of follow-up (with a second session of follow-up following 5-years), beginning on 01/04/2017.
Participants All adult patients (aged