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

This study has been completed.
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: October 30, 2013
Last verified: October 2013
  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.

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 6 weeks and 6 months after operation ] [ Designated as safety issue: No ]

Enrollment: 616
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patients sceduled for elective surgery.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488617

Locations
Germany
Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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: October 30, 2013
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 April 15, 2014