Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-26 @ 1:14 PM
Study NCT ID:
NCT01022567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2018-06-28
First Post:
2009-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D001062', 'term': 'Appendectomy'}, {'id': 'D000077727', 'term': 'Ertapenem'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paulina.salminen@tyks.fi', 'phone': '+358 2 313 0542', 'title': 'Paulina Salminen', 'organization': 'Turku University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Appendectomy', 'description': 'Open appendectomy', 'otherNumAtRisk': 273, 'otherNumAffected': 45, 'seriousNumAtRisk': 273, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Antibiotic Therapy', 'description': 'Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days', 'otherNumAtRisk': 257, 'otherNumAffected': 6, 'seriousNumAtRisk': 257, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Overall morbidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 257, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Appendectomy'}, {'id': 'OG001', 'title': 'Antibiotic Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '100.0'}, {'value': '72.7', 'groupId': 'OG001', 'lowerLimit': '66.8', 'upperLimit': '78.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 years', 'description': 'A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.', 'unitOfMeasure': 'percentage of successful treatment', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment success'}, {'type': 'SECONDARY', 'title': 'The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'The Direct and Indirect Costs of Both Treatment Arms', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'The Recurrence of Conservatively Treated Appendicitis', 'timeFrame': 'up to 10 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2022-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Appendectomy', 'description': 'Open appendectomy'}, {'id': 'FG001', 'title': 'Antibiotic Therapy', 'description': 'Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '257'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '242'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Operative Treatment', 'description': 'Regular open appendicectomy\n\nAppendicectomy: Standard appendicectomy'}, {'id': 'BG001', 'title': 'Antibiotic Treatment', 'description': 'Ertapenem 1 g i.v. x 1 three days\n\nErtapenem: ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2009-11-30', 'resultsFirstSubmitDate': '2016-08-21', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-02', 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis', 'timeFrame': 'Up to 10 years', 'description': 'A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.'}], 'secondaryOutcomes': [{'measure': 'The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment', 'timeFrame': '1 year'}, {'measure': 'The Direct and Indirect Costs of Both Treatment Arms', 'timeFrame': '1 year'}, {'measure': 'The Recurrence of Conservatively Treated Appendicitis', 'timeFrame': 'up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Appendicitis']}, 'referencesModule': {'references': [{'pmid': '23394263', 'type': 'BACKGROUND', 'citation': 'Paajanen H, Gronroos JM, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Dean K, Jartti A, Mecklin JP, Sand J, Salminen P. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial). BMC Surg. 2013 Feb 8;13:3. doi: 10.1186/1471-2482-13-3.'}, {'pmid': '26080338', 'type': 'RESULT', 'citation': 'Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.'}, {'pmid': '40741675', 'type': 'DERIVED', 'citation': 'Selanne L, Hurme S, Sippola S, Rautio T, Nordstrom P, Rantanen T, Pinta T, Ilves I, Mattila A, Savela EL, Rintala J, Paajanen H, Gronroos J, Haijanen J, Salminen P. Prognostic factors associated with primary non-responsiveness to antibiotics and appendicitis recurrence for CT-diagnosed uncomplicated acute appendicitis: secondary analysis of two randomized clinical trials. Br J Surg. 2025 Jul 3;112(7):znaf143. doi: 10.1093/bjs/znaf143.'}, {'pmid': '32074268', 'type': 'DERIVED', 'citation': 'Sippola S, Haijanen J, Viinikainen L, Gronroos J, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Jartti A, Salminen P. Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):283-289. doi: 10.1001/jamasurg.2019.6028.'}, {'pmid': '30264120', 'type': 'DERIVED', 'citation': 'Salminen P, Tuominen R, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Virtanen J, Jartti A, Gronroos JM. Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial. JAMA. 2018 Sep 25;320(12):1259-1265. doi: 10.1001/jama.2018.13201.'}, {'pmid': '28591824', 'type': 'DERIVED', 'citation': 'Niiniviita H, Salminen P, Gronroos JM, Rinta-Kiikka I, Hurme S, Kiljunen T, Kulmala J, Teras M, Sippola S, Virtanen J. LOW-DOSE CT PROTOCOL OPTIMIZATION FOR THE ASSESSMENT OF ACUTE APPENDICITIS: THE OPTICAP PHANTOM STUDY. Radiat Prot Dosimetry. 2018 Jan 1;178(1):20-28. doi: 10.1093/rpd/ncx070.'}]}, 'descriptionModule': {'briefSummary': 'Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.\n\nThe aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 18 to 60 years\n* CT scan diagnosed uncomplicated acute appendicitis\n\nExclusion Criteria:\n\n* Age under 18 years or age over 60 years\n* Pregnancy or breast-feeding\n* Allergy to contrast media or iodine\n* Renal insufficiency\n* metformin medication (DM)\n* Peritonitis (a perforated appendix)\n* Lack of co-operation (unable to give consent)\n* A severe other medical condition\n* CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour'}, 'identificationModule': {'nctId': 'NCT01022567', 'acronym': 'APPAC', 'briefTitle': 'Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis', 'orgStudyIdInfo': {'id': 'APPAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operative treatment', 'description': 'Regular open appendicectomy', 'interventionNames': ['Procedure: Appendicectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic treatment', 'description': 'Ertapenem 1 g i.v. x 1 three days', 'interventionNames': ['Drug: Ertapenem']}], 'interventions': [{'name': 'Appendicectomy', 'type': 'PROCEDURE', 'description': 'Standard appendicectomy', 'armGroupLabels': ['Operative treatment']}, {'name': 'Ertapenem', 'type': 'DRUG', 'description': 'ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.', 'armGroupLabels': ['Antibiotic treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Keski-Suomi Central Hosptal', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'city': 'Mikkeli', 'country': 'Finland', 'facility': 'Mikkeli Central Hospital', 'geoPoint': {'lat': 61.68857, 'lon': 27.27227}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'Seinäjoki Central Hospital', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Paulina Salminen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of surgery, Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Mikkeli Central Hospital', 'class': 'OTHER'}, {'name': 'Jyväskylä Central Hospital', 'class': 'OTHER'}, {'name': 'Seinajoki Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Paulina Salminen', 'investigatorAffiliation': 'Turku University Hospital'}}}}