Outpatient Orthognathic Surgery: "AMBOST" a One Year Study

Orthognathic Surgery Clinical Trial

— AMBOST  

Official title:

Outpatient Orthognathic Surgery: "AMBOST" a One Year Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03486951
• Other study ID #: RC31/18/0045
• Secondary ID: 2018-A00544-51
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: October 2019

Study information

• Verified date: July 2018
• Source: University Hospital, Toulouse
• Contact: Frédéric Lauwers, MD
• Phone: 05 61 77 95 44
• Email: lauwers.f[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Orthognathic Surgery

Intervention

Procedure:
• Orthognathic 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

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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