Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-26 @ 1:18 AM
Study NCT ID:
NCT01732159
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2012-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057189', 'term': 'Checklist'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4093}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-20', 'studyFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in the rate of late cancellation', 'timeFrame': 'At day 0 (the day of the surgery)'}], 'secondaryOutcomes': [{'measure': 'Improvement of the organization of the ambulatory unit', 'timeFrame': 'At day 0 (the day of the surgery)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ambulatory surgery', 'Checklist', 'Cancellation'], 'conditions': ['Ambulatory Surgery Programmed']}, 'referencesModule': {'references': [{'pmid': '26829478', 'type': 'DERIVED', 'citation': 'Gaucher S, Boutron I, Marchand-Maillet F, Baron G, Douard R, Bethoux JP; AMBUPROG Group Investigators. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial. PLoS One. 2016 Feb 1;11(2):e0147194. doi: 10.1371/journal.pone.0147194. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of a check list on the rate of late cancellation, i.e. the day before or the day of the ambulatory surgery.', 'detailedDescription': 'The checklist is administered to the patients by phone between 7 and 3 days before the surgery. Each item of the checklist is associated with a decisional algorithm that allows take care for patients in case of any problem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient (adult or minor) for which ambulatory surgery is programmed in a multipurpose ASU\n* Surgery under general anesthesia or loco\n* Regional or neuroleptanalgesia3. Patient contacted by phone\n* Patient does not oppose his participation in the study\n\nExclusion Criteria:\n\n* Patient programmed for endoscopy in ASU non surgical\n* Ambulatory surgery scheduled for orthogenic\n* Ambulatory surgery scheduled for urgency\n* Ambulatory surgery performed under local anesthesia'}, 'identificationModule': {'nctId': 'NCT01732159', 'acronym': 'AMBUPROG', 'briefTitle': 'Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery', 'orgStudyIdInfo': {'id': 'K110601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of the checklist', 'description': 'Patients will be contacted by phone for administration of the checklist', 'interventionNames': ['Other: Checklist']}, {'type': 'NO_INTERVENTION', 'label': 'No contact by phone', 'description': 'Patients who will not be contacted by phone'}], 'interventions': [{'name': 'Checklist', 'type': 'OTHER', 'description': 'he checklist will be administered to the patients by phone between 7 and 3 days before the surgery', 'armGroupLabels': ['Administration of the checklist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Pierre BETHOUX, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cochin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}