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

This study is currently recruiting participants.
Verified January 2012 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Rita Laufenberg-Feldmann, M.D., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01488617
First received: December 6, 2011
Last updated: January 6, 2012
Last verified: January 2012

December 6, 2011
January 6, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01488617 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Consecutive patients sceduled for elective surgery.

  • Surgery
  • Psychological Distress
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rita Laufenberg-Feldmann, M.D. +496131171 Rita.laufenberg@unimedizin-mainz.de
Germany
 
NCT01488617
MOPS 2012
Yes
Rita Laufenberg-Feldmann, M.D., Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
Not Provided
Principal Investigator: Rita Laufenberg-Feldmann, M.D. Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
Johannes Gutenberg University Mainz
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP