Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-04-10 @ 7:20 PM
Study NCT ID:
NCT01572558
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Treatment of Acute Appendicitis in Children
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': 'D001062', 'term': 'Appendectomy'}, {'id': 'D000077731', 'term': 'Meropenem'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D019985', 'term': 'Benchmarking'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013845', 'term': 'Thienamycins'}, {'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'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D008330', 'term': 'Management Audit'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D015397', 'term': 'Program Evaluation'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-15', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of symptoms without significant complications', 'timeFrame': '30 days', 'description': 'This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment.\n\nFailure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus \\>5 days, length of stay \\>7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy.'}], 'secondaryOutcomes': [{'measure': 'Time in hospital', 'timeFrame': '7 days', 'description': 'Number of days as inpatients after initiation of allocated treatment, ea. after randomization.'}, {'measure': 'Time to resolution of symptoms', 'timeFrame': '7 days', 'description': 'In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia.'}, {'measure': 'Abscess formation', 'timeFrame': '7 days', 'description': 'As noted either in hospital or during follow up.'}, {'measure': 'Early complications', 'timeFrame': '7 days', 'description': 'Wound infections, wound dehiscence, diarrhea etc.'}, {'measure': 'Pain', 'timeFrame': '48 hours', 'description': 'Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Appendectomy', 'Nonsurgical treatment with antibiotics'], 'conditions': ['Appendicitis', 'Child']}, 'referencesModule': {'references': [{'pmid': '31800496', 'type': 'DERIVED', 'citation': 'Patkova B, Svenningsson A, Almstrom M, Eaton S, Wester T, Svensson JF. Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial. Ann Surg. 2020 Jun;271(6):1030-1035. doi: 10.1097/SLA.0000000000003646.'}, {'pmid': '25072441', 'type': 'DERIVED', 'citation': 'Svensson JF, Patkova B, Almstrom M, Naji H, Hall NJ, Eaton S, Pierro A, Wester T. Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2015 Jan;261(1):67-71. doi: 10.1097/SLA.0000000000000835.'}]}, 'descriptionModule': {'briefSummary': 'This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention\n\nExclusion Criteria:\n\n* Suspicion of perforated appendicitis on the basis of generalized peritonitis\n* An appendiceal mass, diagnosed either by palpation or with radiology'}, 'identificationModule': {'nctId': 'NCT01572558', 'acronym': 'CONSAPP Pilot', 'briefTitle': 'Conservative Treatment of Acute Appendicitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Conservative Treatment of Acute Appendicitis in Children Pilot Trial', 'orgStudyIdInfo': {'id': 'EA2011/4:8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Appendectomy', 'description': 'Standard surgical treatment, appendectomy', 'interventionNames': ['Procedure: Appendectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Conservative, non-surgical treatment', 'description': 'Non-operative treatment with intravenous and oral antibiotics', 'interventionNames': ['Drug: Conservative, non-surgical treatment']}], 'interventions': [{'name': 'Appendectomy', 'type': 'PROCEDURE', 'otherNames': ['Open appendectomy', 'Laparoscopic appendectomy'], 'description': 'Standard surgical treatment, normally laparoscopic appendectomy', 'armGroupLabels': ['Appendectomy']}, {'name': 'Conservative, non-surgical treatment', 'type': 'DRUG', 'otherNames': ['Meronem®', 'Meropenem', 'Flagyl®', 'Metronidazol', 'Ciproxin®', 'Ciprofloxacin'], 'description': 'Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.', 'armGroupLabels': ['Conservative, non-surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Astrid Lindgren Children´s Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Jan F Svensson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jan Svensson', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}