NCT01488617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
616

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

December 6, 2011

Last Update Submit

October 30, 2013

Conditions

SurgeryPsychological Distress

Keywords

SurgeryPsychosocial FactorsPsychological DistressOutcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    6 weeks and 6 months after operation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients sceduled for elective surgery.

You may qualify if:

  • Minimum Age 18 Years
  • German language in speaking and writing
  • Capability of giving consent
  • written informed consent

You may not qualify if:

  • Delirium, dementia or other mental disorders with significant cerebral dysfunction
  • People under guardianship
  • simultaneous participation in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany

Mainz, 55131, Germany

Location

Related Publications (2)

  • 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.

    PMID: 29587759DERIVED

  • 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.

    PMID: 27724844DERIVED

Study Officials

  • Rita Laufenberg-Feldmann, M.D.

    Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 8, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations

DE(1)