Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 616
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
The purpose of this study is to determine whether psychological and social factors in addition to medical (physiological) conditions may contribute significantly to the prediction of the postoperative outcome.
Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life.
详细描述
Different factors contribute to the recovery process after surgical intervention. However, little is known about the predictive value of single factors.
In addition to medical (physical) factors, depression, anxiety, somatization and avoiding coping styles are considered as relevant for the successful recovery process. These factors may be defined as "psychological distress" and could be used as predictors for perioperative complications and failed surgical treatment.
Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life.
Our sample includes adults undergoing extensive surgical interventions in trauma and orthopaedic surgery, urology, general surgery, and neurosurgery. The defined variables are measured using standardized and validated questionnaires prior to surgery and in follow-up visits.
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
- •Minimum Age 18 Years
- •German language in speaking and writing
- •Capability of giving consent
- •written informed consent
排除标准
- •Delirium, dementia or other mental disorders with significant cerebral dysfunction
- •People under guardianship
- •simultaneous participation in other clinical studies
结局指标
主要结局
Quality of life
时间窗: 6 weeks and 6 months after operation
次要结局
未报告次要终点
研究者
Rita Laufenberg-Feldmann, M.D.
Principal Investigator
Johannes Gutenberg University Mainz
