Clinical trial NCT03486951: Outpatient Orthognathic Surgery: "AMBOST" a One Year Study
Official title: Outpatient Orthognathic Surgery: "AMBOST" a One Year Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthognathic Surgery
Keywords: outpatient surgery
ambulatory surgery
length of hospital stay
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

The 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.

Eligibility criteria: Inclusion Criteria:

* all patients treated by an orthognathic surgery in Toulouse Teaching Hospital, having given an oral agreement

Exclusion Criteria:

* patient refusal
* inability to understand the information relative to the procedure, the care and the surgical suites
* American Society of Anesthesiology (ASA) Score\>=3
* Severe eating disorders
* Pregnant woman

Primary outcomes:
measure: Rate of outpatient-to-inpatient shifts after an orthognathic procedure
timeFrame: 1 day
Secondary outcomes:
measure: Outpatient rate
timeFrame: 1 day
measure: Causes justifying the shift for patients expected outpatients
timeFrame: 1 day
measure: Factors associated with a conversion in inpatient hospitalization among the patients planned in ambulatory
timeFrame: 1 day
measure: Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis
timeFrame: 1 day
measure: Score of the first 24 hours surgical outcome questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Frédéric Lauwers, MD
role: PRINCIPAL_INVESTIGATOR
References: