|- candidate number||16084|
|- NTR Number||NTR4458|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jan-2014|
|- Secondary IDs||2010/070 METC|
|- Public Title||Research on postoperative functioning of elderly cancer patients|
|- Scientific Title||Postoperative cognitive dysfunction in elderly cancer patients|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Older adults, Cognitive decline, Post operative, Surgery, Onco-geriatric patients|
|- 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). |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||22-jul-2010|
|- planned closingdate||1-jun-2015|
|- Target number of participants||150|
|- Interventions||not applicable.|
|- 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'. |
|- Timepoints||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. |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| B.L. Leeuwen, van|
|- CONTACT for SCIENTIFIC QUERIES|| B.L. Leeuwen, van|
|- Sponsor/Initiator ||University of Groningen|
(Source(s) of Monetary or Material Support)
|University of Groningen|
|- Publications||None. |
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||17-jan-2014 - 14-apr-2014|