Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Johannes Gutenberg University Mainz
- Enrollment
- 616
- Locations
- 1
- Primary Endpoint
- Quality of life
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Rita Laufenberg-Feldmann, M.D.
Principal Investigator
Johannes Gutenberg University Mainz
Eligibility Criteria
Inclusion Criteria
- •Minimum Age 18 Years
- •German language in speaking and writing
- •Capability of giving consent
- •written informed consent
Exclusion Criteria
- •Delirium, dementia or other mental disorders with significant cerebral dysfunction
- •People under guardianship
- •simultaneous participation in other clinical studies
Outcomes
Primary Outcomes
Quality of life
Time Frame: 6 weeks and 6 months after operation