Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT03486951
Status:
UNKNOWN
Last Update Posted:
2018-07-11
First Post:
2018-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outpatient Orthognathic Surgery: "AMBOST" a One Year Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057909', 'term': 'Orthognathic Surgery'}], 'ancestors': [{'id': 'D013515', 'term': 'Surgery, Oral'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of outpatient-to-inpatient shifts after an orthognathic procedure', 'timeFrame': '1 day', 'description': 'An outpatient procedure is considered to have been converted into a traditional hospitalization if there is no discharge the same evening (D0) and therefore the patient has been transferred to a traditional hospitalization unit.\n\nThe procedure is considered to have been performed on an outpatient basis if there was an outpatient discharge the same evening (J0)'}], 'secondaryOutcomes': [{'measure': 'Outpatient rate', 'timeFrame': '1 day', 'description': 'Rate of orthognathic procedures realized in ambulatory among all the scheduled procedures'}, {'measure': 'Causes justifying the shift for patients expected outpatients', 'timeFrame': '1 day', 'description': 'Causes like : pain, nausea-vomiting, slumber, anxiety, logistics)'}, {'measure': 'Factors associated with a conversion in inpatient hospitalization among the patients planned in ambulatory', 'timeFrame': '1 day', 'description': 'Demographic characteristics: age, sex or like Estimated amount of bleeding'}, {'measure': 'Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis', 'timeFrame': '1 day', 'description': 'Total duration of intervention (intubation - extubation)'}, {'measure': 'Score of the first 24 hours surgical outcome questionnaire', 'timeFrame': '1 day', 'description': 'The questionnaire rating each adverse effect from 0 (no discomfort) to 4 (very important discomfort)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outpatient surgery', 'ambulatory surgery', 'length of hospital stay'], 'conditions': ['Orthognathic Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. The investigator also wants to identify factors associated with an outpatient-to-inpatient shift, and factors associated with the duration of hospitalization.', 'detailedDescription': 'In Toulouse Teaching Hospital, the annual number of orthognathic surgery outpatient stays was multiplied by 6 since 2010, indicating a new trend of theses procedures. Outpatient stays presents several advantages for the patient and for the health system: decrease of the psychological stress, higher satisfaction, minimization of the personal and domestic activity interruption, less exposure to nosocomial infections, decrease of global costs, increase of the population rate which can be treated. However, very few data report the experience of outpatient orthognathic surgery in France and the factors associated with its success or failure.\n\nThe choice of ambulatory versus complete hospitalization is decided during preoperative consultation by the surgeon in agreement with the patient. The classic surgical and anesthetic protocol of orthognathic surgery is applied whatever the type of hospitalization. The data are collected from the patient medical record (electronic patient record, orthognathic follow-up form, anesthetic sheet) and from a patient quality of life questionnaire. There is no modification of the usual follow-up, patients are seen at D-8 which is the end-study visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Are not excluded from the study the minor patients, for reasons of collection bias: the population benefiting from an orthognathic surgery is carried out mainly on an adolescent population at the end of growth, to exclude these patients would therefore be a major bias to conducting the study and analyzing the results.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients treated by an orthognathic surgery in Toulouse Teaching Hospital, having given an oral agreement\n\nExclusion Criteria:\n\n* patient refusal\n* inability to understand the information relative to the procedure, the care and the surgical suites\n* American Society of Anesthesiology (ASA) Score\\>=3\n* Severe eating disorders\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT03486951', 'acronym': 'AMBOST', 'briefTitle': 'Outpatient Orthognathic Surgery: "AMBOST" a One Year Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Outpatient Orthognathic Surgery: "AMBOST" a One Year Prospective Study', 'orgStudyIdInfo': {'id': 'RC31/18/0045'}, 'secondaryIdInfos': [{'id': '2018-A00544-51', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Orthognathic Surgery:', 'type': 'PROCEDURE', 'description': "maxillary/mandibular osteotomies for orthognathic purposes for the treatment of a dento-maxillary dysharmony The choice between outpatient procedure or hospitalization is decided by the surgeon on a case-by-case basis according to data relating to the general state of the patient, the type of surgery, the social context, the distance from the patient's home. a medical center in accordance with the usual and legal standards of outpatient surgery"}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Frédéric Lauwers, MD', 'role': 'CONTACT', 'email': 'lauwers.f@chu-toulouse.fr', 'phone': '05 61 77 9 544', 'phoneExt': '33'}, {'name': 'isabelle Olivier, PhD', 'role': 'CONTACT', 'email': 'olivier.i@chu-toulouse.fr', 'phone': '05 61 77 70 51', 'phoneExt': '33'}], 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Frédéric Lauwers, MD', 'role': 'CONTACT', 'email': 'lauwers.f@chu-toulouse.fr', 'phone': '05 61 77 95 44', 'phoneExt': '33'}, {'name': 'Isabelle Olivier, PhD', 'role': 'CONTACT', 'email': 'olivier.i@chu-toulouse.fr', 'phone': '05 61 77 70 51', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Frédéric Lauwers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}