Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis (ACTUAA)

January 6, 2020 updated by: Mauro Podda

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cagliari, Italy, 09042
        • General and Endocrine Surgical Unit, Cagliari University Hospital, Cagliari
      • Cagliari, Italy, 09121
        • General Surgery, Santissima Trinità Hospital
      • Napoli, Italy, 80147
        • Emergency Surgery Unit, Villa Betania Evangelic Hospital, Napoli
      • Nuoro, Italy, 08100
        • General, Minimally Invasive and Robotic Surgery, San Francesco Hospital
    • Cagliari
      • Muravera, Cagliari, Italy, 09043
        • General and Emergency Surgery Unit, San Marcellino Hospital
    • Italt
      • Rome, Italt, Italy
        • Department of General Surgery, San Giovanni Addolorata Hospital
    • Ogliastra
      • Lanusei, Ogliastra, Italy, 08045
        • General Surgery Unit, Nostra Signora Della Mercede Hospita, Lanusei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

All adult patients (aged over 18 years old) with suspected Acute Appendicitis admitted to the Surgical Department of the nine participating Italian Hospitals

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients submitted to appendectomy as first-line treatment
Open or Laparoscopic Appendectomy The assignment of each patient to either the "antibiotic-first management" arm or the "immediate surgery" arm, will be non-randomized and decided independently by the Staff Specialist Surgeon on Call, upon careful assessment of AIR score, laboratory findings and imaging. The decision of the management pathway will not be influenced in any case by the participation of the patient in the study, and the assignment of the treatment will be decided by the consultant surgeon according to current good surgical practice and standard practice patterns in Italy.
Procedure: Laparoscopic or Open appendectomy
Laparoscopic three-port or single-port appendectomy; or conventional McBurney laparotomic appendectomy; or open appendectomy performed through midline incision
Patients treated with antibiotic-first strategy
Antibiotic therapy.maging. Patients managed conservatively will receive one of the following parenteral antibiotic treatments: Piperacillin/Tazobactam (4.5 g) three intravenous administration per day; Ceftriaxone (2 g) once per day or Ciprofloxacin (500 mg) twice per day plus Metronidazole (500 mg) three times per day; Amoxicillin/Clavulanic acid (2 g) four times per day for a length depending on the clinical conditions; Ertapenem (1 g) one administration per day for three days. Patients were discharged with oral antibiotics (amoxicillin/clavulanic acid or ciprofloxacin) for at least four days.
Drug: Antibiotic-first therapy
Patients treated with antibiotics as first-line approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complication-free treatment success, as assessed by the Dindo-Clavien Scale.
Time Frame: 1 year
Number of participants with complication-free treatment success, defined as success of the initial treatment with uncomplicated course: no postoperative complications, adverse events, or treatment failure occurring, as assessed by the Dindo-Clavien Classification. Post-treatment abdominal abscess, bowel occlusion, incisional hernia, pulmonary embolism, cardio-vascular complications, surgical site infection, complications due to anesthesia, adverse reactions to antibiotics. Complications are analyzed both for patients submitted to appendectomy and for those treated with surgery as second line approach, after primary antibiotic treatment failure. For patients treated with antibiotics, treatment failure (persistency and recurrence rates of acute appendicitis) will be evaluated within the overall-complications rate. Specific sub-analyses of the complications will be carried out.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 1 week
Length of post-operative hospital stay for patients submitted to appendectomy; length of hospital stay for patients treated with antibiotics
1 week
VAS-Score
Time Frame: 1 month
Pain evaluation performed through the visual analogue scale both for patients who undergo an appendectomy and for those treated with antibiotics
1 month
Time to return to normal activity
Time Frame: 1 month
Time to return to normal activity both for patients who undergo an appendectomy and for those treated with antibiotics
1 month
Period of sick-leave
Time Frame: 1 month
Period of sick-leave, intended as "absence from work"
1 month
Complicated appendicitis with peritonitis identified at the time of surgical operation.
Time Frame: 1 year
In the antibiotic group the analysis will be carried out within the cohort of patients who will undergo appendectomy after the failure of the antibiotic therapy in order to assess whether or not a major risk of perforated appendicitis exists for patients who will be treated firstly with antibiotics.
1 year
Quality of life as assessed by the Short Form 12-scale (SF-12)
Time Frame: 1 year
Quality of life estimated by the Short Form 12-scale (SF-12)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mauro Podda

Collaborators

Associazione Chirurghi Ospedalieri Italiani

Investigators

  • Study Director: Mauro Podda, M.D., Associazione dei Chirurghi Ospedalieri Italiani ACOI; General Surgeon, San Francesco Hospital. Nuoro (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

March 5, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (ACTUAL)

March 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No ID (Other Grant/Funding Number: Smartee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be published as a pool from all participating surgical units. Subgroup analysis by grade of the disease based on the AIR score, surgical technique, histological grade of the appendicitis, type of antibiotic used or outcome variables may be presented, but, in order to avoid the identification of an individual unit or surgeon, no hospital level or surgeon level data will be published.Each participating centre, with equal right, will be able to access the data of the registry, perform statistical analysis, discuss the results and freely write scientific manuscripts. Each study that is generated based on the registry must be disseminated to all the centres before final publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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