Outpatient Orthognathic Surgery: "AMBOST" a One Year Study

• Conditions: Orthognathic Surgery

• Registration Number: NCT03486951
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11
• Study Start: 2018-09
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of outpatient-to-inpatient shifts after an orthognathic procedure	1 day	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.; The procedure is considered to have been performed on an outpatient basis if there was an outpatient discharge the same evening (J0)

Secondary Outcome Measures

Name	Time	Method
Score of the first 24 hours surgical outcome questionnaire	1 day	The questionnaire rating each adverse effect from 0 (no discomfort) to 4 (very important discomfort)
Causes justifying the shift for patients expected outpatients	1 day	Causes like : pain, nausea-vomiting, slumber, anxiety, logistics)
Outpatient rate	1 day	Rate of orthognathic procedures realized in ambulatory among all the scheduled procedures
Factors associated with a conversion in inpatient hospitalization among the patients planned in ambulatory	1 day	Demographic characteristics: age, sex or like Estimated amount of bleeding
Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis	1 day	Total duration of intervention (intubation - extubation)

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France