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Trial record 3 of 201 for:    MOPS

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488617
First Posted: December 8, 2011
Last Update Posted: October 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rita Laufenberg-Feldmann, M.D., Johannes Gutenberg University Mainz
  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 Rita Laufenberg-Feldmann, M.D., Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 6 weeks and 6 months after operation ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: December 6, 2011
First Posted: December 8, 2011
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by Rita Laufenberg-Feldmann, M.D., Johannes Gutenberg University Mainz:
Surgery
Psychosocial Factors
Psychological Distress
Outcome Assessment (Health Care)