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

Completed

• Conditions: Surgery; Psychological Distress

• Registration Number: NCT01488617
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-08
• Study Start: 2012-01
• Primary Completion: 2013-08
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 616

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life	6 weeks and 6 months after operation

Trial Locations

Locations (1)

Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany; 🇩🇪 Mainz, Germany