Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01420367
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2011-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Are Post-operative Antibiotics Indicated in Simple Appendicitis?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'C537984', 'term': 'Charcot-Marie-Tooth disease, Type 1C'}], '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': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-08-18', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of post-operative infection in the six weeks following appendectomy', 'timeFrame': '6 weeks', 'description': 'Defined by wound infection, fever (\\>38.5) or evidence of sepsis.'}, {'measure': 'Requirement of further antibiotic therapy in the six weeks following appendectomy', 'timeFrame': '6 weeks', 'description': 'Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period.'}], 'secondaryOutcomes': [{'measure': 'Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria', 'timeFrame': '1 week', 'description': 'Discharge criteria:\n\nPain adequately controlled with oral analgesia Tolerating full diet Afebrile'}, {'measure': 'Re-admission in the six weeks following appendectomy', 'timeFrame': '6 weeks', 'description': 'Re-admission to the treating hospital or any other hospital in the 6 weeks post-operative period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Paediatric', 'Simple', 'Non-perforated'], 'conditions': ['Appendicitis']}, 'descriptionModule': {'briefSummary': "Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime in preventing post-operative complications in paediatric patients with simple appendicitis.\n\nThis project will compare patients 16 years and under with simple appendicitis (appendicitis that is not perforated or gangrenous). Patients will be randomly divided into two groups;\n\n* Group one will receive a single pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline (placebo) eight and sixteen hours after the initial dose, respectively.\n* Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen hours after the first dose, respectively.\n\nGroup allocation will be concealed from the patient and their guardian, the treating surgical team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if required will be in place.\n\nThe aim of the study is to determine if a single dose of antibiotics is as effective as three doses in preventing post-operative infection. This will be assessed by comparing:\n\n* Duration of hospital stay from operation until discharge, based on a standardised discharge criteria.\n* Development of wound infection or requirement of antibiotics in the six weeks post-operation\n* Need for re-admission.\n\nInformation will be collected prospectively from each patient's hospital notes and from a follow-up phone call six weeks after the operation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients who have their appendix removed and are found on operation to have 'simple appendicitis' as defined in the Cochrane review\\[7\\]. That is an appendix that is non-inflamed, acutely inflamed, phlegmonous, suppurative or mildly inflamed.\n\nExclusion Criteria:\n\n* Patients who on operation are found to have 'complicated appendicitis' defined as an appendix that is gangrenous or perforated.\n* Patients who pre-operatively appear to be acutely septic or for another reason require extended antibiotic therapy.\n* Patients who, at operation, are found to have other pathology e.g. Meckel's Diverticulum, Intussusception; requiring surgical or medical intervention.\n* Any patient whose guardian does not wish for them to participate in the study.\n* Patients who have additional co-morbidities, including diabetes, immuno-suppression, cardiac, renal or liver failure.\n* If the child continues to show sign of sepsis, in terms of fever, tachycardia, he/she will be discontinued from the study and be given additional doses of antibiotics, as clinically indicated."}, 'identificationModule': {'nctId': 'NCT01420367', 'briefTitle': 'Are Post-operative Antibiotics Indicated in Simple Appendicitis?', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Are Post-operative Antibiotics Indicated in Simple Appendicitis? a Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'U1111-1123-7877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose of antibiotics', 'description': "This group will receive one dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) in the pre-operative period and two post-operative IV 'doses' of normal saline 8 and 16 hours after the pre-operative dose, which will act as a placebo and facilitate blinding.", 'interventionNames': ['Drug: metronidazole and cephalzolin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Three doses of antibiotics', 'description': 'This group will receive one pre-operative dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) and two post-operative doses of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) 8 and 16 hours after the pre-operative dose.', 'interventionNames': ['Drug: metronidazole and cephalzolin']}], 'interventions': [{'name': 'metronidazole and cephalzolin', 'type': 'DRUG', 'description': 'IV doses of metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g). One dose for study arm, two for comparative arm.', 'armGroupLabels': ['Single dose of antibiotics', 'Three doses of antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}], 'overallOfficials': [{'name': 'Nicole Mennie, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Wei Cheng, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Monash Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Monash Medical Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}