No registrations found.
ID
Source
Brief title
Health condition
Older adults, postoperative cognitive decline, functional decline, inflammatory response, onco-geriatric patients, surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
A change in cognitive functioning at two weeks, three months and one year postoperatively as measured by the Ruff Figural Fluency Test, Trailmaking Test and Rey's verbal learning test in comparison to the preoperative scores.
Secondary outcome
- postoperative delirium
- postoperative complications
- one year mortality
- physical performance status
- quality of life
Background summary
Onco-geriatric surgical patients are at an increased risk of postoperative complications. Especially postoperative cognitive impairment has an enormous impact on quality of life and daily functioning in this population.
An inflammatory response to surgery seems to be related to the development of postoperative cognitive decline, delirium and other postoperative complications.
The aim of this study is to investigate the effects of this inflammatory response and identify predictors and possible confounders like preoperative inflammation level, muscle strength, nutritional status and general functioning on this effect.
Study objective
The effects of the inflammatory response to a surgical procedure on postoperative cognitive decline in elderly cancer patients will be investigated. Preoperative inflammation level, muscle strength, nutritional status and general functioning will be investigated as possible confounders of postoperative impairment.
Study design
preoperatively, at hospital discharge or two weeks postoperatively and three months and one year postoperatively
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 anaesthesia.
• written informed consent given according to local regulations.
• Patients can only be included in this trial once.
Exclusion criteria
• any physical condition potentially hampering compliance with the study protocol and follow-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 | NL4441 |
| NTR-old | NTR4564 |
| Other | : METc2014/095 |