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Predicting postoperative outcome in elderly surgical cancer patients. Biomarkers and handgrip strength as predictors of postoperative outcome in elderly


- candidate number16085
- NTR NumberNTR4564
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jan-2014
- Secondary IDsMETc2014/095 
- Public TitlePredicting postoperative outcome in elderly surgical cancer patients. Biomarkers and handgrip strength as predictors of postoperative outcome in elderly
- Scientific TitlePredicting postoperative outcome in elderly surgical cancer patients. Biomarkers and handgrip strength as predictors of postoperative outcome in elderly
- ACRONYMPICNIC BHAPPY
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedOlder 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 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)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type[default]
- Studytypeobservational
- planned startdate 1-jun-2014
- planned closingdate1-jun-2019
- Target number of participants672
- InterventionsNot applicable
- Primary outcomeA 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
- Timepointspreoperatively, at hospital discharge or two weeks postoperatively and three months and one year postoperatively
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES B.L. Leeuwen, van
- CONTACT for SCIENTIFIC QUERIES B.L. Leeuwen, van
- Sponsor/Initiator University of Groningen
- Funding
(Source(s) of Monetary or Material Support)
University of Groningen
- PublicationsNone
- Brief summaryOnco-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.
- Main changes (audit trail)
- RECORD17-jan-2014 - 1-jun-2014


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