Acute Appendicitis Clinical Trial
Official title:
A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).
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 over 18 years old) with suspected AA will be admitted
to the Surgical Department of the nine participating Italian hospitals, where they will be
studied carefully by the on call surgeon.
Patients will be then informed of the study protocol and invited to give written consent for
participation and for sensible data collection for scientific purposes.
Subsequently, only patients who will undergo diagnostic imaging (as specified later) and from
whom a written informed consent will be obtained, can be enrolled in the study and registered
by each Center using a uniform electronic registration form and database.
General characteristics, medical history, clinical findings, physical investigation, and
blood tests will be reported in the medical record. Pain will be quantified by Visual
Analogue Scale (VAS) scoring system before administrating any pain medications and after the
treatments.
In order to enter the study, patients will have to undergo diagnostic imaging (US and/or CT
scan or MRI scan) and only the diagnosis of uncomplicated AA confirmed by diagnostic imaging
will permit patient enrollment in the study.
Specific aims of the ACTUAA Study The objective of this prospective non-randomized
controlled, multicenter, multidisciplinary trial is to compare the antibiotic therapy and
emergency appendectomy for the treatment of patients with uncomplicated AA(without abscess or
free perforation), confirmed by US and/or CT or MRI scan. No changes in the daily practice
regarding the diagnostic, clinical and treatment pathways will be required to the
participating centers. However, only the patients with uncomplicated AA, confirmed by one of
the above mentioned radiologic tools will be enrolled in the study. The decision on which of
the tools are to be adopted will be up to the local lead surgeon.
Primary Outcome Measure:
Number of participants with complication-free treatment success, defined as success of the
initial treatment with uncomplicated course.
Secondary Outcome Measures:
Length of hospital stay; Pain evaluation; Time to return to normal activity; Period of
sick-leave; Complicated appendicitis with peritonitis identified at the time of surgical
operation; Quality of life as assessed by the Short Form 12-scale (SF-12)
n/a
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