Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 9:07 AM
Study NCT ID:
NCT01738750
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2012-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], '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'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eric.scaife@imail2.org', 'phone': '801-662-2950', 'title': 'Dr. Eric Scaife', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cost Information Included', 'description': 'Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.\n\nCost Information Included', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Cost Information Included', 'description': 'Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Choice Based on Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cost Information Included', 'description': 'Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy'}, {'id': 'OG001', 'title': 'No Cost Information Included', 'description': 'Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Outcome assessed prior to surgical procedure with data presented within 1 year', 'description': 'The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information', 'unitOfMeasure': 'percentage of open appendectomy', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital/Operative Dollars', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dollar Information Included', 'description': 'Group of patients that will receive dollars information for both the laparoscopic and open surgical procedures prior to choice of procedure.\n\nDollars Information Included'}, {'id': 'OG001', 'title': 'No Dollar Information Included', 'description': 'Group of patients that will not receive dollar information for the laparoscopic and open surgical procedures prior to choice of procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '9,949', 'groupId': 'OG000', 'lowerLimit': '8,601', 'upperLimit': '11,338'}, {'value': '10,477', 'groupId': 'OG001', 'lowerLimit': '9,213', 'upperLimit': '11,972'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year', 'description': 'A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups', 'unitOfMeasure': 'Dollar', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cost Information Included', 'description': 'Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.\n\nCost Information Included'}, {'id': 'FG001', 'title': 'No Cost Information Included', 'description': 'Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cost Information Included', 'description': 'Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.\n\nCost Information Included'}, {'id': 'BG001', 'title': 'No Cost Information Included', 'description': 'Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '10.7', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Age, Gender'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2012-11-22', 'resultsFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-16', 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Choice Based on Cost', 'timeFrame': 'Outcome assessed prior to surgical procedure with data presented within 1 year', 'description': 'The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information'}], 'secondaryOutcomes': [{'measure': 'Hospital/Operative Dollars', 'timeFrame': 'Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year', 'description': 'A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surgical choice', 'cost of care', 'decision making', 'health care', 'health care cost', 'pediatric', 'children', 'appendicitis', 'patient satisfaction'], 'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '25185471', 'type': 'DERIVED', 'citation': 'Russell KW, Rollins MD, Barnhart DC, Mone MC, Meyers RL, Skarda DE, Soukup ES, Black RE, Molitor MS, Stoddard GJ, Scaife ER. Charge Awareness Affects Treatment Choice: Prospective Randomized Trial in Pediatric Appendectomy. Ann Surg. 2015 Jul;262(1):189-93. doi: 10.1097/SLA.0000000000000885.'}]}, 'descriptionModule': {'briefSummary': 'This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.\n\nChildren admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure.\n\nThe hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute appendicitis\n\nExclusion Criteria:\n\n* age 18 or older\n* imaging positive for perforation; ultrasound or CT scan\n* pain for greater than 2 days\n* children with a body mass index \\> 95% for age and sex\n* surgeon decision for non-equivalent procedure based on patient presentation'}, 'identificationModule': {'nctId': 'NCT01738750', 'briefTitle': 'Laparoscopic Versus Open Appendectomy? Let the Patient Decide', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Laparoscopic Versus Open Appendectomy? Let the Patient Decide', 'orgStudyIdInfo': {'id': 'UU56320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cost Information Included', 'description': 'Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.', 'interventionNames': ['Other: Cost Information Included']}, {'type': 'NO_INTERVENTION', 'label': 'No Cost Information Included', 'description': 'Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.'}], 'interventions': [{'name': 'Cost Information Included', 'type': 'OTHER', 'armGroupLabels': ['Cost Information Included']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Eric Scaife, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}