跳至主要内容
临床试验/NCT05176990
NCT05176990已完成不适用

Evaluation of the Safety of Ambulatory Surgery in Senology and Gynecology Within the Paris Saint-Joseph Hospital Group

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 991 人开始时间: 2021年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
991
试验地点
1
主要终点
Complication rate of ambulatory surgery

研究概览

简要总结

Ambulatory surgery is defined as "surgical procedures scheduled and performed under technical conditions that imperatively require the safety of an operating room, under an anesthesia of variable mode and followed by a postoperative monitoring allowing, without increased risk, the discharge of the patient on the same day of his intervention.

It therefore does not include hospital accommodation and represents an alternative to traditional hospitalization.

Ambulatory surgery is of interest in a growing number of situations. Its interest lies on the one hand in the obvious economic interest and in the fact that this model corresponds to the expectations of patients in 2021, allowing them to return to their usual living environment as soon as possible. It also reduces the risk of infections associated with care, due to the short duration of the stay and the minimally invasive surgical techniques, without compromising safety conditions.

It therefore requires a well-designed circuit, ensuring the quality and safety of care at all stages, to allow an early return home without risk.

Since 2011, the French National Authority for Health has defined outpatient surgery as a priority objective in France, setting a target of 70% of surgeries performed as outpatient procedures by 2022.

Currently, less than 50% of surgery in France is performed on an outpatient basis, compared to 65% in Belgium, in Northern European countries and even 85% in the United States.

As early as 2001, the Assurance Maladie identified gynecological surgery as a surgery with a high potential for development in ambulatory care, particularly breast surgery and gynecological laparoscopy.

Many gynecological surgeries benefit from this type of management, in particular because of the low level of patient comorbidity, but the risks of failure are difficult to predict because of the small amount of data available in the literature, particularly in gynecology.

Paris Saint-Joseph Hospital inaugurated the Ambulatory Surgery Unit (ASU) in 2018, with a well-defined patient pathway, and outpatient surgical activity in gynecology represents 15% of activity among the 9 surgical disciplines.

The aim of this study is therefore to evaluate the safety of ambulatory management of patients operated on at the GHPSJ in the ambulatory surgery unit, in the context of breast surgery or gynaecological surgery, by assessing complications and their risk factors.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient whose age ≥ 18 years
  • Patient eligible for outpatient surgery
  • Patient operated in gynecology at HPSJ in UCA from 01/05/2020 to 31/05/2021
  • French-speaking patient

排除标准

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of her data for this research

结局指标

主要结局

Complication rate of ambulatory surgery

时间窗: Day 30

This outcome corresponds to a composite criterion corresponding to the Conversion of stay to traditional hospitalization Or revision of surgery within 30 days Or re-hospitalization within 30 days Or emergency room visit within 30 days.

次要结局

  • Emergency room visit(Day 30)
  • Conversion of stay to traditional hospitalization(Day 30)
  • Revision of surgery(Day 30)
  • Re-hospitalization(Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验