Psycho-Social Outcomes Following Emergency Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- The change in patient reported Quality of Life as assessed by the EuroQuol 5-Dimension Health-related Quality of Life instrument (EQ-5D)
研究概览
简要总结
An emergency laparotomy (EmLap) is a life-saving operation; but the aftermath for those that do survive can be lifechanging. Each year, in excess of 25,000 EmLaps are performed in UK. A national effort, through the National Emergency Laparotomy Audit (NELA), has managed to improve peri-operative care, and reduce 30 day mortality from 1 in 4 to less than 1 in 10. Whilst this reduction should be commended, it also means that more patients are surviving with some form of new infirmity.
This infirmity may be short-lived and reversible in some, and yet others may transition into a permanent chronic disease state. The impact of EmLap on those individuals that "do not fully recover" is far-reaching and often interlinked, covering biological, social and psychological domains. This makes it difficult to describe the true problem, i.e. holistic morbidity and suggest an intervention to improve it.
The primary aim of this work is to describe the holistic morbidity of EmLap throughout the first year of a patient's recovery.
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
- •18 years or above
- •Able to communicate in English
- •Cognitively able to complete the questionnaire
- •Able to provide informed voluntary consent
- •Undergone an EmLap during admission
- •Clinical team anticipate to be "medically fit for discharge" within 48 hours (of consent)
排除标准
- •Any terminal diagnosis in which the clinical team do not anticipate life expectancy to exceed 6 months from the time of surgery
- •Acutely unwell at the time of recruitment. These patients may still be eligible and can be re-screened and recruited at a later date, should their condition improve.
结局指标
主要结局
The change in patient reported Quality of Life as assessed by the EuroQuol 5-Dimension Health-related Quality of Life instrument (EQ-5D)
时间窗: 12 months
Patient reported Quality of Life will be measured at 3 time points post-discharge. Reduction of EQ-5D 3-Level scale (min.5; max 15) and EQ-5D Visual Analogue Scale (min 0; max. 100) represent improved quality of life.
次要结局
- Establishing the patient definition of 'Recovery' following Emergency Laparotomy using qualitative methods(12 months)
- Change in Fatigue Severity Score(12 months)
- Change in Body Mass Index(12 months)
- Change in Rockwood Frailty Score(12 months)
- Change in Gastro-Intestinal Quality of Life Index(12 months)
- Change in International Trauma Questionnaire score(12 months)
- Change in Patient Health Questionnaire score(12 months)
- Change in Generalised Anxiety Disorder assessment score(12 months)
- Changes in Community Integration Questionnaire score(12 months)
- Change in sexual function(12 months)
- Change in employment status(12 months)
- The changes in care burden as assessed by the Modified Caregiver Strain Index (MCSI)(12 months)