Outpatient Orthognathic Surgery: "AMBOST" a One Year Study

NCT ID: NCT03486951

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2019-10-31

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.

Conditions

Orthognathic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Lauwers, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Countries

France

Central Contacts

Frédéric Lauwers, MD

Role: CONTACT

lauwers.f@chu-toulouse.fr

05 61 77 95 44 ext. 33

Isabelle Olivier, PhD

Role: CONTACT

olivier.i@chu-toulouse.fr

05 61 77 70 51 ext. 33

Facility Contacts

Frédéric Lauwers, MD

Role: primary

lauwers.f@chu-toulouse.fr

05 61 77 9 544 ext. 33

isabelle Olivier, PhD

Role: backup

olivier.i@chu-toulouse.fr

05 61 77 70 51 ext. 33

Other Identifiers

2018-A00544-51

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0045

Identifier Type: -

Identifier Source: org_study_id