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临床试验/NCT03486951
NCT03486951Unknown不适用

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

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Rate of outpatient-to-inpatient shifts after an orthognathic procedure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Rate of outpatient-to-inpatient shifts after an orthognathic procedure

时间窗: 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)

次要结局

  • Score of the first 24 hours surgical outcome questionnaire(1 day)
  • Causes justifying the shift for patients expected outpatients(1 day)
  • Outpatient rate(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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