Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02576405
Other study ID # SG
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 13, 2015
Last updated October 14, 2015
Start date October 2015
Est. completion date March 2017

Study information

Verified date September 2015
Source Rigshospitalet, Denmark
Contact Silas Gylvin, MD
Phone +45 51 29 68 05
Email silasgylvin@gmail.com
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

It has been established that patients with psychiatric disorders tend to do worse in a surgical setting. Some types of surgery with greater impact than others, including orthopedic surgery. In our research group the investigators have shown this to be the case for hip and knee replacements within the mentioned patient category. However, the role of psychiatric disorder and use of different psychopharmacological drugs in relation to perioperative morbidity and mortality have not been thoroughly examined. The objective of this study is to shed light on the issue.

Recent studies have shown that different types of psychiatric disorder influence surgical outcome differently. This emphasizes the need for specific knowledge regarding psychiatric diagnoses preoperatively. In this study around 2000 patients with or without psychiatric disorder of any kind will be studied preoperatively, which according to our previous study will include more than 200 patients receiving psychopharmacological treatment. The specifics that characterize every patient's psychiatric trades will be included in a validated questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen. Preoperative information regarding their mental condition and medicine will be linked to surgical outcome in order to identify potential hazards in the perioperative period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date March 2017
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients planned for elective unilateral fast-track hip or knee arthroplasty.

- Age > 18.

- Can understand and read danish.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty Patients
  • Mental Disorders

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological characterization of hip and knee arthroplasty patients using the validated SCL-92 questionnaire 90 days postoperatively No
Secondary Length of stay 90 days postoperatively No
Secondary Readmissions 30 and 90 days postoperatively No