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Outpatient Orthognathic Surgery: AMBOST a One Year Study

Outpatient Orthognathic Surgery: AMBOST a One Year Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03486951
Acronym
AMBOST
Enrollment
100
Registered
2018-04-03
Start date
2018-09-30
Completion date
2019-10-31
Last updated
2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthognathic Surgery

Keywords

outpatient surgery, ambulatory surgery, length of hospital stay

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.

Interventions

PROCEDUREOrthognathic Surgery:

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of outpatient-to-inpatient shifts after an orthognathic procedure1 dayAn 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. The procedure is considered to have been performed on an outpatient basis if there was an outpatient discharge the same evening (J0)

Secondary

MeasureTime frameDescription
Outpatient rate1 dayRate of orthognathic procedures realized in ambulatory among all the scheduled procedures
Causes justifying the shift for patients expected outpatients1 dayCauses like : pain, nausea-vomiting, slumber, anxiety, logistics)
Factors associated with a conversion in inpatient hospitalization among the patients planned in ambulatory1 dayDemographic characteristics: age, sex or like Estimated amount of bleeding
Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis1 dayTotal duration of intervention (intubation - extubation)
Score of the first 24 hours surgical outcome questionnaire1 dayThe questionnaire rating each adverse effect from 0 (no discomfort) to 4 (very important discomfort)

Countries

France

Contacts

Primary ContactFrédéric Lauwers, MD
lauwers.f@chu-toulouse.fr05 61 77 95 44
Backup ContactIsabelle Olivier, PhD
olivier.i@chu-toulouse.fr05 61 77 70 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026