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Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis (ACTUAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080103
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Associazione Chirurghi Ospedalieri Italiani
Information provided by (Responsible Party):
Mauro Podda, Associazione Chirurghi Ospedalieri Italiani

Study Description
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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)


Condition or disease Intervention/treatment
Acute Appendicitis Appendicitis Recurrent Appendectomy Antibiotic Therapy Procedure: Laparoscopic or Open appendectomy Drug: Antibiotic-first therapy

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Period of sick-leave [ Time Frame: 1 month ]
    Period of sick-leave, intended as "absence from work"

  5. 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.

  6. 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)


Biospecimen Retention:   Samples With DNA
Specimens of the appendix

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080103


Locations
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Italy
General and Emergency Surgery Unit, San Marcellino Hospital
Muravera, Cagliari, Italy, 09043
Department of General Surgery, San Giovanni Addolorata Hospital
Rome, Italt, Italy
General Surgery Unit, Nostra Signora Della Mercede Hospita, Lanusei
Lanusei, Ogliastra, Italy, 08045
General and Endocrine Surgical Unit, Cagliari University Hospital, Cagliari
Cagliari, Italy, 09042
General Surgery, Santissima Trinità Hospital
Cagliari, Italy, 09121
Emergency Surgery Unit, Villa Betania Evangelic Hospital, Napoli
Napoli, Italy, 80147
General, Minimally Invasive and Robotic Surgery, San Francesco Hospital
Nuoro, Italy, 08100
Sponsors and Collaborators
Mauro Podda
Associazione Chirurghi Ospedalieri Italiani
Investigators
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Study Director: Mauro Podda, M.D. Associazione dei Chirurghi Ospedalieri Italiani ACOI; General Surgeon, San Francesco Hospital. Nuoro (Italy)
More Information
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Publications:
Sartelli M, Catena F, Ansaloni L, Coccolini F, Griffiths EA, Abu-Zidan FM, Di Saverio S, Ulrych J, Kluger Y, Ben-Ishay O, Moore FA, Ivatury RR, Coimbra R, Peitzman AB, Leppaniemi A, Fraga GP, Maier RV, Chiara O, Kashuk J, Sakakushev B, Weber DG, Latifi R, Biffl W, Bala M, Karamarkovic A, Inaba K, Ordonez CA, Hecker A, Augustin G, Demetrashvili Z, Melo RB, Marwah S, Zachariah SK, Shelat VG, McFarlane M, Rems M, Gomes CA, Faro MP, Júnior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Çolak E, Isik A, Rios-Cruz D, Soto R, Moore EE. WSES Guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016 Jul 29;11:37. doi: 10.1186/s13017-016-0095-0. eCollection 2016. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mauro Podda, Dr. Mauro Podda, M.D., Associazione Chirurghi Ospedalieri Italiani
ClinicalTrials.gov Identifier: NCT03080103    
Other Study ID Numbers: No ID
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Podda, Associazione Chirurghi Ospedalieri Italiani:
Acute Appendicitis
Uncomplicated Acute Appendicitis
Appendectomy
Conservative Treatment
 Antibiotic-first Treatment
Recurrent Appendicitis
Prospective Study
Additional relevant MeSH terms:
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Appendicitis
Acute Disease
Intraabdominal Infections
Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents