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.
ID
Bron
Verkorte titel
Aandoening
elder patients, postoperative cognitive dysfunction, onco-geriatric, surgery
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
not applicable.
Publiek
P.O. Box 30.001
B.L. Leeuwen, van
Groningen 9700 RB
The Netherlands
+31 (0)50 3612301
blvleeuwen@hetnet
Wetenschappelijk
P.O. Box 30.001
B.L. Leeuwen, van
Groningen 9700 RB
The Netherlands
+31 (0)50 3612301
blvleeuwen@hetnet
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4219 |
| NTR-old | NTR4458 |
| Ander register | METC : 2010/070 |