Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Predictors for Postoperative Outcome (MOPS)
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Purpose
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.
| Condition |
|---|
|
Surgery Psychological Distress |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome. |
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Consecutive patients sceduled for elective surgery.
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
Contacts and Locations| Contact: Rita Laufenberg-Feldmann, M.D. | +496131171 | Rita.laufenberg@unimedizin-mainz.de |
| Germany | |
| Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany | Recruiting |
| Mainz, Germany, 55131 | |
| Principal Investigator: | Rita Laufenberg-Feldmann, M.D. | Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany |
More Information
No publications provided
| Responsible Party: | Rita Laufenberg-Feldmann, M.D., Principal Investigator, Johannes Gutenberg University Mainz |
| ClinicalTrials.gov Identifier: | NCT01488617 History of Changes |
| Other Study ID Numbers: | MOPS 2012 |
| Study First Received: | December 6, 2011 |
| Last Updated: | January 6, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Johannes Gutenberg University Mainz:
|
Surgery Psychosocial Factors Psychological Distress Outcome Assessment (Health Care) |
ClinicalTrials.gov processed this record on June 18, 2013