Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT02766257
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of ambulatory surgery', 'timeFrame': '1day', 'description': 'number of patients that have been hospitalized (for whom ambulatory have been conversed to hospitalization)'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '3 days', 'description': 'Number of patients that presented complications of anesthesia or surgery such as nausea, vomiting, drowsiness and fever.'}, {'measure': 'Complication after discharge from hospital', 'timeFrame': '3 days', 'description': 'number of phone calls from parents of patients after ambulatory discharge'}]}, 'conditionsModule': {'conditions': ['Complications']}, 'referencesModule': {'references': [{'pmid': '28067703', 'type': 'DERIVED', 'citation': 'Kabre YB, Traore IS, Kabore FA, Ki B, Traore AI, Ouedraogo I, Bandre E, Wandaogo A, Ouedraogo N. Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa: A Pilot Study in Burkina Faso. Anesth Analg. 2017 Feb;124(2):623-626. doi: 10.1213/ANE.0000000000001780.'}]}, 'descriptionModule': {'briefSummary': 'Long surgical wait-times and limited hospital capacity are common obstacles to surgical care in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to these problems. The aim is to study the introduction of ambulatory surgery in a pediatric hospital in SSA.\n\nThis is a cross-sectional descriptive study which took place over 6 months. It includes all the patients assigned to ambulatory surgery in the Pediatric University Hospital in Ouagadougou, Burkina Faso.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 status\n* elective surgery with low potential for blood loss or severe pain, lasting less than 90 minutes\n* whose parents could be contacted by telephone and who could return to the hospital in less than 1 hour\n* Parents gave consent for the surgical procedure\n\nExclusion Criteria:\n\n* non operative patients'}, 'identificationModule': {'nctId': 'NCT02766257', 'briefTitle': 'Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle'}, 'officialTitle': 'Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA): a Pilot Study in Burkina Faso', 'orgStudyIdInfo': {'id': 'A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'children undergoing ambulatory surgery', 'interventionNames': ['Procedure: Anesthesia for ambulatory paediatric surgery']}], 'interventions': [{'name': 'Anesthesia for ambulatory paediatric surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['children undergoing ambulatory surgery']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}