Outpatient Orthognathic Surgery: "AMBOST" a One Year Study

NCT03486951 | Unknown

• 2 other identifiers: RC31/18/00452018-A00544-51
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthognathic Surgery

Keywords

outpatient surgery; ambulatory surgery; length of hospital stay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Outpatient rate

  1 day

• Causes justifying the shift for patients expected outpatients

  1 day

• Factors associated with a conversion in inpatient hospitalization among the patients planned in ambulatory

  1 day

• Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis

  1 day

• Score of the first 24 hours surgical outcome questionnaire

  1 day

Interventions

Orthognathic Surgery: PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• all patients treated by an orthognathic surgery in Toulouse Teaching Hospital, having given an oral agreement

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Orthognathic Surgery

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Frédéric Lauwers, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Lauwers, MD

CONTACT

05 61 77 95 44; lauwers.f@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 3, 2018
• Study Start: September 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)