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临床试验/NCT01488617
NCT01488617已完成不适用

Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.

Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2012年1月最近更新:
适应症

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

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

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rita Laufenberg-Feldmann, M.D.

Principal Investigator

Johannes Gutenberg University Mainz

研究点 (1)

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