A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 主要终点
- Number of participants with complications & changes over time points.
研究概览
简要总结
Background: Complications impact physical and psychological recovery and are associated with financial cost. General physical function has not been studied in relation to the development of surgical complications in this cohort.
Objective: Evaluate the physical function performance differences between those who develop complications and those who do not and determine their impact on recovery.
Design: Observational Setting: The pre-operative assessment unit in the University Hospital Limerick. Patients: Forty-nine participants who were planned to undergo abdominal surgery were recruited & 43 completed the study.
Main outcome measure: Demographics, physical function, lung function, surgical parameters, complications and recovery data was collected.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent to participate in the study
- •Eighteen years or above
- •Planned for elective abdominal surgery
- •American Society of Anaesthesia physical status score <4.
排除标准
- •Abdominal surgery within one year prior to study entry
- •Unable or unwilling to give informed consent
- •Inability (cognitive) to perform the pre-operative tests, as characterised by inability to understand the information in the patient information leaflet
- •Current systemic acute illness
- •Scheduled for non-abdominal surgery
- •Unstable angina or myocardial infarction in the previous month
- •Physical limitation precluding inability to participate in pre-operative tests.
结局指标
主要结局
Number of participants with complications & changes over time points.
时间窗: (1) 0-29 days, (2) 30 and (3) 60 days post operatively
Defined as occuring within the first 30 days post-operatively using the Clavien Dindo classification
次要结局
- Spirometry to measure lung function(2-4 weeks pre-operatively)
- Thirty Second Sit to Stand Test to measure endurance(2-4 weeks pre-operatively)
- Changes in perceived recovery over time(30 and 60 days post operatively)
- Peak Cough Flow to measure cough strength(2-4 weeks pre-operatively)
- Grip strength.(2-4 weeks pre-operatively)
- Change over time in activity levels.((1) 2-4 weeks pre-operatively, (2) 30 and (3) 60 days post operatively)
- Six Minute Walk Test to measure exercise capacity(2-4 weeks pre-operatively)
研究者
mary flahive
Senior Physiotherapist, Practice Tutor
University Hospital of Limerick