Clinical trial NCT03080103: Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis
Official title: A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Appendicitis Recurrent
Appendectomy
Antibiotic Therapy
Keywords: Acute Appendicitis
Uncomplicated Acute Appendicitis
Appendectomy
Conservative Treatment
Antibiotic-first Treatment
Recurrent Appendicitis
Prospective Study
Lead sponsor: Associazione Chirurghi Ospedalieri Italiani
Sponsor class: OTHER
Collaborators: name: Associazione Chirurghi Ospedalieri Italiani
First posted: 2017-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients (aged over 18 years old) with suspected Acute Appendicitis admitted to the Surgical Department of the nine participating Italian Hospitals

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 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)


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age over 18 years
* Uncomplicated AA confirmed by US and/or CT or MRI scan.

Exclusion Criteria:

* Pregnancy or lactating
* Diffuse peritonitis at physical examination
* Serious systemic illness
* Positive anamnesis for Inflammatory Bowel Disease (IBD)

Primary outcomes:
measure: Number of participants with complication-free treatment success, as assessed by the Dindo-Clavien Scale.
timeFrame: 1 year
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 week
measure: VAS-Score
timeFrame: 1 month
measure: Time to return to normal activity
timeFrame: 1 month
measure: Period of sick-leave
timeFrame: 1 month
measure: Complicated appendicitis with peritonitis identified at the time of surgical operation.
timeFrame: 1 year
measure: Quality of life as assessed by the Short Form 12-scale (SF-12)
timeFrame: 1 year
Other outcomes:
Locations:
city: Muravera
country: Italy
facility: General and Emergency Surgery Unit, San Marcellino Hospital
state: Cagliari
city: Rome
country: Italy
facility: Department of General Surgery, San Giovanni Addolorata Hospital
state: Italt
city: Lanusei
country: Italy
facility: General Surgery Unit, Nostra Signora Della Mercede Hospita, Lanusei
state: Ogliastra
city: Cagliari
country: Italy
facility: General and Endocrine Surgical Unit, Cagliari University Hospital, Cagliari
city: Cagliari
country: Italy
facility: General Surgery, Santissima Trinità Hospital
city: Napoli
country: Italy
facility: Emergency Surgery Unit, Villa Betania Evangelic Hospital, Napoli
city: Nuoro
country: Italy
facility: General, Minimally Invasive and Robotic Surgery, San Francesco Hospital
Study officials:
affiliation: Associazione dei Chirurghi Ospedalieri Italiani ACOI; General Surgeon, San Francesco Hospital. Nuoro (Italy)
name: Mauro Podda, M.D.
role: STUDY_DIRECTOR
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