NCT01488617

Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Predictors for Postoperative Outcome

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 616 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery
• Psychological Distress

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2011-12-08
• Last updated: 2013-10-31

Locations

1 site across 1 country: Germany