Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT00435032
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2007-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Versus Interval Appendectomy for Ruptured 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2007-02-12', 'studyFirstSubmitQcDate': '2007-02-13', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time (days) away from normal activities (or time until returns to normal activities)', 'timeFrame': 'At completion of study'}], 'secondaryOutcomes': [{'measure': 'complication rates of each treatment arm:', 'timeFrame': 'At completion of study'}, {'measure': 'Wound infection or dehiscence', 'timeFrame': 'Throughout study period'}, {'measure': 'Intra-abdominal abscess', 'timeFrame': 'Throughout study period'}, {'measure': 'Requires reoperation', 'timeFrame': 'Throughout study period'}, {'measure': 'Bowel obstruction', 'timeFrame': 'Throughout study period'}, {'measure': 'central venous catheter-related infection', 'timeFrame': 'Throughout study period'}, {'measure': 'interventional radiology-related complication', 'timeFrame': 'Throughout study period'}, {'measure': 'Total hospital length of stay', 'timeFrame': 'At study completion'}, {'measure': '# patients with central venous line', 'timeFrame': 'At study completion'}, {'measure': '# with interventional radiology drainage', 'timeFrame': 'At study completion'}, {'measure': '# of return visits to pediatrician, ED, surgery office', 'timeFrame': 'At study completion'}, {'measure': 'Other complication', 'timeFrame': 'At study completion'}, {'measure': 'quality of life questionnaire (SF10)', 'timeFrame': 'At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment'}, {'measure': 'hospital costs', 'timeFrame': 'At study completion'}]}, 'conditionsModule': {'keywords': ['ruptured appendicitis', 'children', 'surgery', 'randomized trial'], 'conditions': ['Ruptured Appendicitis']}, 'referencesModule': {'references': [{'pmid': '21339413', 'type': 'DERIVED', 'citation': 'Blakely ML, Williams R, Dassinger MS, Eubanks JW 3rd, Fischer P, Huang EY, Paton E, Culbreath B, Hester A, Streck C, Hixson SD, Langham MR Jr. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg. 2011 Jun;146(6):660-5. doi: 10.1001/archsurg.2011.6. Epub 2011 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.', 'detailedDescription': 'There are two surgical treatment options for children with ruptured appendicitis. Early appendectomy is one option and typically involves removing the ruptured appendix after several hours of optimizing the patient medically with intravenous fluids and intravenous antibiotics. Another option, interval appendectomy, uses the same initial fluid and antibiotic management, but delays removing the appendix until 6-8 weeks later. The rationale for delaying the appendectomy is to perform the operation at a time when the patient is perhaps more stable and the abdominal cavity is free from contamination. Both of these treatment options are currently used by many pediatric surgeons across the United States and both appear to work well. The two treatment have never been compared in any prospective study. The primary outcome of the study is the time that a patient (and family) is away from normal activities, due to the disease and its treatment. Secondary outcome measures include complication rates, quality of life measures (SF10), hospital cost analysis, and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ruptured appendicitis\n\nExclusion Criteria:\n\n* Inability to have usual follow up care (e.g. transient to area)'}, 'identificationModule': {'nctId': 'NCT00435032', 'acronym': 'RAPTOR', 'briefTitle': 'Early Versus Interval Appendectomy for Ruptured Appendicitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)', 'orgStudyIdInfo': {'id': 'R073223335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Early appendectomy', 'interventionNames': ['Procedure: early appendectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Interval appendectomy', 'interventionNames': ['Procedure: interval appendectomy']}], 'interventions': [{'name': 'early appendectomy', 'type': 'PROCEDURE', 'description': 'Appendectomy within 24 hours of admission', 'armGroupLabels': ['1']}, {'name': 'interval appendectomy', 'type': 'PROCEDURE', 'description': 'Initial antibiotic treatment followed by appendectomy at 6-8 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "LeBonheur Children's Medical Center", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Martin L Blakely, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Tennessee Health Science Center, LeBonheur Children's Medical Center"}, {'name': 'Barbara Culbreath, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': "University of Tennessee Health Science Center, LeBonheur Children's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Martin Blakely', 'oldOrganization': 'University of Tennessee'}}}}