Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-01 @ 4:31 PM
Study NCT ID:
NCT03080103
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2017-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Specimens of the appendix'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2017-03-05', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with complication-free treatment success, as assessed by the Dindo-Clavien Scale.', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '1 week', 'description': 'Length of post-operative hospital stay for patients submitted to appendectomy; length of hospital stay for patients treated with antibiotics'}, {'measure': 'VAS-Score', 'timeFrame': '1 month', 'description': 'Pain evaluation performed through the visual analogue scale both for patients who undergo an appendectomy and for those treated with antibiotics'}, {'measure': 'Time to return to normal activity', 'timeFrame': '1 month', 'description': 'Time to return to normal activity both for patients who undergo an appendectomy and for those treated with antibiotics'}, {'measure': 'Period of sick-leave', 'timeFrame': '1 month', 'description': 'Period of sick-leave, intended as "absence from work"'}, {'measure': 'Complicated appendicitis with peritonitis identified at the time of surgical operation.', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Quality of life as assessed by the Short Form 12-scale (SF-12)', 'timeFrame': '1 year', 'description': 'Quality of life estimated by the Short Form 12-scale (SF-12)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Appendicitis', 'Uncomplicated Acute Appendicitis', 'Appendectomy', 'Conservative Treatment', 'Antibiotic-first Treatment', 'Recurrent Appendicitis', 'Prospective Study'], 'conditions': ['Acute Appendicitis', 'Appendicitis Recurrent', 'Appendectomy', 'Antibiotic Therapy']}, 'referencesModule': {'references': [{'pmid': '15174387', 'type': 'BACKGROUND', 'citation': 'DeFrances CJ, Hall MJ. 2002 National Hospital Discharge Survey. Adv Data. 2004 May 21;(342):1-29.'}, {'pmid': '17522514', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2239906', 'type': 'BACKGROUND', 'citation': 'Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. 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Epub 2016 Aug 29.'}, {'pmid': '27478494', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16135930', 'type': 'BACKGROUND', 'citation': 'Katkhouda N, Mason RJ, Towfigh S, Gevorgyan A, Essani R. 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Effectiveness of a staged US and CT protocol for the diagnosis of pediatric appendicitis: reducing radiation exposure in the age of ALARA. Radiology. 2011 Apr;259(1):231-9. doi: 10.1148/radiol.10100984. Epub 2011 Jan 28.'}, {'pmid': '25598112', 'type': 'BACKGROUND', 'citation': 'Nielsen JW, Boomer L, Kurtovic K, Lee E, Kupzyk K, Mallory R, Adler B, Bates DG, Kenney B. Reducing computed tomography scans for appendicitis by introduction of a standardized and validated ultrasonography report template. J Pediatr Surg. 2015 Jan;50(1):144-8. doi: 10.1016/j.jpedsurg.2014.10.033. Epub 2014 Dec 18.'}, {'pmid': '24590746', 'type': 'BACKGROUND', 'citation': 'Aspelund G, Fingeret A, Gross E, Kessler D, Keung C, Thirumoorthi A, Oh PS, Behr G, Chen S, Lampl B, Middlesworth W, Kandel J, Ruzal-Shapiro C. Ultrasonography/MRI versus CT for diagnosing appendicitis. Pediatrics. 2014 Apr;133(4):586-93. doi: 10.1542/peds.2013-2128. Epub 2014 Mar 3.'}, {'pmid': '10644120', 'type': 'BACKGROUND', 'citation': 'Rettenbacher T, Hollerweger A, Macheiner P, Rettenbacher L, Frass R, Schneider B, Gritzmann N. Presence or absence of gas in the appendix: additional criteria to rule out or confirm acute appendicitis--evaluation with US. Radiology. 2000 Jan;214(1):183-7. doi: 10.1148/radiology.214.1.r00ja20183.'}, {'pmid': '26883138', 'type': 'BACKGROUND', 'citation': 'Mostbeck G, Adam EJ, Nielsen MB, Claudon M, Clevert D, Nicolau C, Nyhsen C, Owens CM. How to diagnose acute appendicitis: ultrasound first. Insights Imaging. 2016 Apr;7(2):255-63. doi: 10.1007/s13244-016-0469-6. Epub 2016 Feb 16.'}, {'pmid': '23996381', 'type': 'BACKGROUND', 'citation': 'Quigley AJ, Stafrace S. Ultrasound assessment of acute appendicitis in paediatric patients: methodology and pictorial overview of findings seen. Insights Imaging. 2013 Dec;4(6):741-51. doi: 10.1007/s13244-013-0275-3. 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Epub 2014 Apr 23.'}, {'pmid': '17114626', 'type': 'BACKGROUND', 'citation': 'Bixby SD, Lucey BC, Soto JA, Theysohn JM, Ozonoff A, Varghese JC. Perforated versus nonperforated acute appendicitis: accuracy of multidetector CT detection. Radiology. 2006 Dec;241(3):780-6. doi: 10.1148/radiol.2413051896.'}, {'pmid': '25427333', 'type': 'BACKGROUND', 'citation': 'Ramdass MJ, Young Sing Q, Milne D, Mooteeram J, Barrow S. Association between the appendix and the fecalith in adults. Can J Surg. 2015 Feb;58(1):10-4. doi: 10.1503/cjs.002014.'}, {'pmid': '33454817', 'type': 'DERIVED', 'citation': 'Podda M, Poillucci G, Pacella D, Mortola L, Canfora A, Aresu S, Pisano M, Erdas E, Pisanu A, Cillara N; ACTUAA Study Collaborative Working Group. Appendectomy versus conservative treatment with antibiotics for patients with uncomplicated acute appendicitis: a propensity score-matched analysis of patient-centered outcomes (the ACTUAA prospective multicenter trial). Int J Colorectal Dis. 2021 Mar;36(3):589-598. doi: 10.1007/s00384-021-03843-8. Epub 2021 Jan 17.'}, {'pmid': '28812175', 'type': 'DERIVED', 'citation': 'Podda M, Serventi F, Mortola L, Marini S, Sirigu D, Piga M, Pisano M, Coppola M, Agresta F, Virdis F, Di Saverio S, Cillara N; ACTUAA Study Collaborative Working Group. A prospective non-randomized controlled, multicenter trial comparing Appendectomy and Conservative Treatment for Patients with Uncomplicated Acute Appendicitis (the ACTUAA study). Int J Colorectal Dis. 2017 Nov;32(11):1649-1660. doi: 10.1007/s00384-017-2878-5. Epub 2017 Aug 15.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nTo 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.\n\nTo 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.\n\nTo 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.\n\nTo evaluate the sensibility and specificity of clinical and laboratory scores for the diagnosis of uncomplicated AA.\n\nTo identify a subgroup of patients with uncomplicated AA for whom antibiotic treatment can be highly effective.\n\nGeneral study design The study protocol is designed according to the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials".\n\nThe 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.\n\nParticipants 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.\n\nPatients will be then informed of the study protocol and invited to give written consent for participation and for sensible data collection for scientific purposes.\n\nSubsequently, 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.\n\nGeneral 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.\n\nIn 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.\n\nSpecific 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.\n\nPrimary Outcome Measure:\n\nNumber of participants with complication-free treatment success, defined as success of the initial treatment with uncomplicated course.\n\nSecondary Outcome Measures:\n\nLength 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (aged over 18 years old) with suspected Acute Appendicitis admitted to the Surgical Department of the nine participating Italian Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Age over 18 years\n* Uncomplicated AA confirmed by US and/or CT or MRI scan.\n\nExclusion Criteria:\n\n* Pregnancy or lactating\n* Diffuse peritonitis at physical examination\n* Serious systemic illness\n* Positive anamnesis for Inflammatory Bowel Disease (IBD)'}, 'identificationModule': {'nctId': 'NCT03080103', 'acronym': 'ACTUAA', 'briefTitle': 'Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Associazione Chirurghi Ospedalieri Italiani'}, 'officialTitle': 'A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).', 'orgStudyIdInfo': {'id': 'No ID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients submitted to appendectomy as first-line treatment', 'description': '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.', 'interventionNames': ['Procedure: Laparoscopic or Open appendectomy']}, {'label': 'Patients treated with antibiotic-first strategy', 'description': '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.', 'interventionNames': ['Drug: Antibiotic-first therapy']}], 'interventions': [{'name': 'Laparoscopic or Open appendectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic three-port or single-port appendectomy; or conventional McBurney laparotomic appendectomy; or open appendectomy performed through midline incision', 'armGroupLabels': ['Patients submitted to appendectomy as first-line treatment']}, {'name': 'Antibiotic-first therapy', 'type': 'DRUG', 'description': 'Patients treated with antibiotics as first-line approach', 'armGroupLabels': ['Patients treated with antibiotic-first strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09043', 'city': 'Muravera', 'state': 'Cagliari', 'country': 'Italy', 'facility': 'General and Emergency Surgery Unit, San Marcellino Hospital', 'geoPoint': {'lat': 39.41972, 'lon': 9.57471}}, {'city': 'Rome', 'state': 'Italt', 'country': 'Italy', 'facility': 'Department of General Surgery, San Giovanni Addolorata Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '08045', 'city': 'Lanusei', 'state': 'Ogliastra', 'country': 'Italy', 'facility': 'General Surgery Unit, Nostra Signora Della Mercede Hospita, Lanusei', 'geoPoint': {'lat': 39.87927, 'lon': 9.54022}}, {'zip': '09042', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'General and Endocrine Surgical Unit, Cagliari University Hospital, Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '09121', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'General Surgery, Santissima Trinità Hospital', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '80147', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Emergency Surgery Unit, Villa Betania Evangelic Hospital, Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '08100', 'city': 'Nuoro', 'country': 'Italy', 'facility': 'General, Minimally Invasive and Robotic Surgery, San Francesco Hospital', 'geoPoint': {'lat': 40.31991, 'lon': 9.32568}}], 'overallOfficials': [{'name': 'Mauro Podda, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associazione dei Chirurghi Ospedalieri Italiani ACOI; General Surgeon, San Francesco Hospital. Nuoro (Italy)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mauro Podda', 'class': 'OTHER'}, 'collaborators': [{'name': 'Associazione Chirurghi Ospedalieri Italiani', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Mauro Podda, M.D.', 'investigatorFullName': 'Mauro Podda', 'investigatorAffiliation': 'Associazione Chirurghi Ospedalieri Italiani'}}}}