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Acute AppendicitisACTUAANCT03080103

Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis

An observational study of Acute Appendicitis and Appendicitis Recurrent, run by Mauro Podda at 7 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laparoscopic or Open appendectomy and Antibiotic-first therapy
How many people
300 participants
Where
7 sitesItaly
Study dates
1 Jun 2017to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Italy7 sites

  • General and Endocrine Surgical Unit, Cagliari University Hospital, Cagliari

    Cagliari, 09042

  • General Surgery, Santissima Trinità Hospital

    Cagliari, 09121

  • General Surgery Unit, Nostra Signora Della Mercede Hospita, Lanusei

    Lanusei, Ogliastra, 08045

  • General and Emergency Surgery Unit, San Marcellino Hospital

    Muravera, Cagliari, 09043

  • Emergency Surgery Unit, Villa Betania Evangelic Hospital, Napoli

    Naples, 80147

  • General, Minimally Invasive and Robotic Surgery, San Francesco Hospital

    Nuoro, 08100

  • Department of General Surgery, San Giovanni Addolorata Hospital

    Rome, Italt

Other trials in Italy

About this study

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.

Read more

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)

Being tested
Laparoscopic or Open appendectomy, Antibiotic-first therapy
Keywords
Acute Appendicitis, Uncomplicated Acute Appendicitis, Appendectomy, Conservative Treatment, Antibiotic-first Treatment, Recurrent Appendicitis, Prospective Study
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic or Open appendectomyProcedure or surgery

    Laparoscopic three-port or single-port appendectomy; or conventional McBurney laparotomic appendectomy; or open appendectomy performed through midline incision

  • Antibiotic-first therapyDrug

    Patients treated with antibiotics as first-line approach

Study groups in NCT03080103
Study groupRoleWhat they receive
Patients submitted to appendectomy as first-line treatmentOpen 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.
Receives: Procedure: Laparoscopic or Open appendectomy
Patients treated with antibiotic-first strategyAntibiotic 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.
Receives: Drug: Antibiotic-first therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with complication-free treatment success, as assessed by the Dindo-Clavien Scale.

    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.

    Measured: 1 year

Secondary outcomes (6)

  1. Length of hospital stay

    Length of post-operative hospital stay for patients submitted to appendectomy; length of hospital stay for patients treated with antibiotics

    Measured: 1 week

  2. VAS-Score

    Pain evaluation performed through the visual analogue scale both for patients who undergo an appendectomy and for those treated with antibiotics

    Measured: 1 month

  3. Time to return to normal activity

    Time to return to normal activity both for patients who undergo an appendectomy and for those treated with antibiotics

    Measured: 1 month

  4. Period of sick-leave

    Period of sick-leave, intended as "absence from work"

    Measured: 1 month

  5. Complicated appendicitis with peritonitis identified at the time of surgical operation.

    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.

    Measured: 1 year

  6. Quality of life as assessed by the Short Form 12-scale (SF-12)

    Quality of life estimated by the Short Form 12-scale (SF-12)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study start1 Jun 2017
  3. Primary completion30 Jun 2018
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080103
Sponsor's protocol ID
No ID
Acronym
ACTUAA
Status last verified
Jan 2020
First submitted
5 Mar 2017
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • DeFrances CJ, Hall MJ. 2002 National Hospital Discharge Survey. Adv Data. 2004 May 21;(342):1-29.

    PubMed 15174387

  • Livingston EH, Woodward WA, Sarosi GA, Haley RW. Disconnect between incidence of nonperforated and perforated appendicitis: implications for pathophysiology and management. Ann Surg. 2007 Jun;245(6):886-92. doi: 10.1097/01.sla.0000256391.05233.aa.

    PubMed 17522514

  • Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. doi: 10.1093/oxfordjournals.aje.a115734.

    PubMed 2239906

  • Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.

    PubMed 27437029

  • Agresta F, Campanile FC, Podda M, Cillara N, Pernazza G, Giaccaglia V, Ciccoritti L, Ioia G, Mandala S, La Barbera C, Birindelli A, Sartelli M, Di Saverio S; Joined Italian Surgical Societies Working Group. Current status of laparoscopy for acute abdomen in Italy: a critical appraisal of 2012 clinical guidelines from two consecutive nationwide surveys with analysis of 271,323 cases over 5 years. Surg Endosc. 2017 Apr;31(4):1785-1795. doi: 10.1007/s00464-016-5175-4. Epub 2016 Aug 29.

    PubMed 27572068

  • 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, Junior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Colak 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.

    PubMed 27478494

  • Katkhouda N, Mason RJ, Towfigh S, Gevorgyan A, Essani R. Laparoscopic versus open appendectomy: a prospective randomized double-blind study. Ann Surg. 2005 Sep;242(3):439-48; discussion 448-50. doi: 10.1097/01.sla.0000179648.75373.2f.

    PubMed 16135930

  • Di Saverio S, Sartelli M, Catena F, Birindelli A, Tugnoli G. Renewed Interest in Acute Appendicitis: Are Antibiotics Non-Inferior to Surgery or Possibly Clinically Superior? What Is Long-Term Follow-Up and Natural Evolution of Appendicitis Treated Conservatively with "Antibiotics First"? Surg Infect (Larchmt). 2016 Jun;17(3):376-7. doi: 10.1089/sur.2015.206. Epub 2016 Feb 26. No abstract available.

    PubMed 26918798

  • Liu K, Fogg L. Use of antibiotics alone for treatment of uncomplicated acute appendicitis: a systematic review and meta-analysis. Surgery. 2011 Oct;150(4):673-83. doi: 10.1016/j.surg.2011.08.018.

    PubMed 22000179

  • Nakhamiyayev V, Galldin L, Chiarello M, Lumba A, Gorecki PJ. Laparoscopic appendectomy is the preferred approach for appendicitis: a retrospective review of two practice patterns. Surg Endosc. 2010 Apr;24(4):859-64. doi: 10.1007/s00464-009-0678-x.

    PubMed 19730948

  • Flum DR, Koepsell T. The clinical and economic correlates of misdiagnosed appendicitis: nationwide analysis. Arch Surg. 2002 Jul;137(7):799-804; discussion 804. doi: 10.1001/archsurg.137.7.799.

    PubMed 12093335

  • Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granstrom L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. doi: 10.1007/s00268-005-0304-6.

    PubMed 16736333

  • Turhan AN, Kapan S, Kutukcu E, Yigitbas H, Hatipoglu S, Aygun E. Comparison of operative and non operative management of acute appendicitis. Ulus Travma Acil Cerrahi Derg. 2009 Sep;15(5):459-62.

    PubMed 19779986

  • Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.

    PubMed 21550483

  • Podda M, Cillara N, Di Saverio S, Lai A, Feroci F, Luridiana G, Agresta F, Vettoretto N; ACOI (Italian Society of Hospital Surgeons) Study Group on Acute Appendicitis. Antibiotics-first strategy for uncomplicated acute appendicitis in adults is associated with increased rates of peritonitis at surgery. A systematic review with meta-analysis of randomized controlled trials comparing appendectomy and non-operative management with antibiotics. Surgeon. 2017 Oct;15(5):303-314. doi: 10.1016/j.surge.2017.02.001. Epub 2017 Mar 9.

    PubMed 28284517

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Appendicitis and Appendicitis Recurrent, run by Mauro Podda at 7 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with complication-free treatment success, as assessed by the Dindo-Clavien Scale. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03080103, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

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