Outpatient Orthognathic Surgery: "AMBOST" a One Year Study (AMBOST)

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

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.

Study Overview

• Status: Unknown
• Conditions: Orthognathic Surgery
• Intervention / Treatment: Procedure: Orthognathic Surgery:

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outpatient rate	Rate of orthognathic procedures realized in ambulatory among all the scheduled procedures	1 day
Causes justifying the shift for patients expected outpatients	Causes like : pain, nausea-vomiting, slumber, anxiety, logistics)	1 day
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
Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis	Total duration of intervention (intubation - extubation)	1 day
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Frédéric LAUWERS, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: outpatient surgery; length of hospital stay; ambulatory surgery
• Other Study ID Numbers: RC31/18/0045; 2018-A00544-51 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No