Clinical trial NCT01488617: Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Predictors for Postoperative Outcome
Official title: Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Psychological Distress
Keywords: Surgery
Psychosocial Factors
Psychological Distress
Outcome Assessment (Health Care)
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients sceduled for elective surgery.

Brief 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.

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 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

Primary outcomes:
measure: Quality of life
timeFrame: 6 weeks and 6 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
Study officials:
affiliation: Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
name: Rita Laufenberg-Feldmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laufenberg-Feldmann R, Kappis B, Camara RJA, Ferner M. Anxiety and its predictive value for pain and regular analgesic intake after lumbar disc surgery - a prospective observational longitudinal study. BMC Psychiatry. 2018 Mar 27;18(1):82. doi: 10.1186/s12888-018-1652-8.
citation: Laufenberg-Feldmann R, Kappis B, Mauff S, Schmidtmann I, Ferner M. Prevalence of pain 6 months after surgery: a prospective observational study. BMC Anesthesiol. 2016 Oct 10;16(1):91. doi: 10.1186/s12871-016-0261-7.