No registrations found.
ID
Source
Brief title
Health condition
elder patients, postoperative cognitive dysfunction, onco-geriatric, surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of POCD defined by a postoperative change in cognitive function measured by the Ruff Figural Fluency score and Trailmaking test score in comparison to the preoperative score.
Secondary outcome
- memory, measured by the Rey's verbal learning test.
- daily functioning and quality of life measured by the instruments in the 'Minimale Dataset'.
Background summary
POCD is a phenomenon that has an enormous impact on the ability of elderly patients to function independently in everyday life. In this observational pilot study experience will be obtained in diagnosing POCD and its risk factors in onco-geriatric surgical patients.
Study objective
The purpose of this study is to gain experience in diagnosing Postoperative Cognitive Dysfunction (POCD) and its risk factors in surgical patients from the age of 65 years undergoing a surgical procedure for a solid malignant tumor.
Study design
The tests will be performed at the most 1 month preoperatively and at discharge (or a maximum of 2 weeks postoperatively) and 3 months and 1 year postoperatively.
Blood and saliva samples will be obtained pre-, per- and postoperatively to determine cortisol levels as a parameter of peroperative stress and interleukin-6 levels as a parameter to determine the operative immuneresponse.
Intervention
not applicable.
P.O. Box 30.001
B.L. Leeuwen, van
Groningen 9700 RB
The Netherlands
+31 (0)50 3612301
blvleeuwen@hetnet
P.O. Box 30.001
B.L. Leeuwen, van
Groningen 9700 RB
The Netherlands
+31 (0)50 3612301
blvleeuwen@hetnet
Inclusion criteria
- Surgery is scheduled more than 24 hours after inclusion in the study as we feel this is the time necessary to obtain test results and plan the intraoperative recording of data.
- surgery under general, local or regional anesthesia.
- written informed consent given according to local regulations.
Exclusion criteria
- any physical condition potentially hampering complicance with the study protocol and follo up schedule, this includes: severe visual impairment, total deafness or the inability to hold a pencil.
- personal time constraints unabling patients to comply to the study protocol.
- patients unable to comply with the outcome questionnaires (this includes insufficient knowledge of the Dutch language).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4219 |
| NTR-old | NTR4458 |
| Other | METC : 2010/070 |