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

Surgery Clinical Trial

— MOPS  

Official title:

Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488617
• Other study ID #: MOPS 2012
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: October 30, 2013
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psychological Distress
• Surgery

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		6 weeks and 6 months after operation	No