跳至主要内容
临床试验/NCT02895607
NCT02895607已完成不适用

Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Assessment of pain by visual analogue scale VAS

研究概览

简要总结

Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.

Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.

However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).

The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.

详细描述

II. objectives

at. primary objective

Rating (or "feasibility") of a management protocol HDJ of ACL reconstruction in a hospital structure on a multi-operator series.

Evaluation criteria (absence of EG)?

b. secondary objectives

研究设计

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

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Isolated ACL tear
  • First arthroscopic reconstruction at DIDT

排除标准

  • Age over 60 years
  • ASA score greater than 2
  • Geographical remoteness
  • Social isolation
  • medical condition requiring supervision by HC (phlebitis history, coagulation disorders ...)
  • psychiatric pathology

结局指标

主要结局

Assessment of pain by visual analogue scale VAS

时间窗: Day 45

Evaluation of pain by visual analogue scale (VAS was numerical scale from 0 = no pain to 10 = unbearable pain)

次要结局

  • Assessment of Patient satisfaction(Day 45)
  • Assessment of sleep quality(Day 45)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验