1) Postoperative cognitive dysfunction 2) functionloss after surgery
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients over 65 years of age undergoing surgery for a solid malignancy. 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. Patients can only be included in this trial once.;Control group: Patients
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is a postoperative change in cognitive functioning. Cognitive functioning will be measured by the scores of the Ruff Figural Fluency (RFFT), the Trailmaking test (TMT) part A en B and Rey*s verbal learning test in comparison to the preoperative scores(26-29). These tests will be submitted at the most 1 month preoperatively and at discharge (or a maximum of 2 weeks postoperatively) and 3 and 12 months postoperatively. There is no uniform definition for POCD in the literature(30). Based on recommendations from a review from Ghoneim and Block our endpoint is defined as a postoperative cognitive decline, which will be analysed by a combined Z-score from the above mentioned tests. With this score predictors of cognitive decline can be investigated. As a reference value for the calculated Z-scores, values of scores on cognitive tests in the general population are available. To increase comparability with other studies the scores on the cognitive tests will also be analysed as continuous endpoints(30). Comparison to the general population Cognitive functioning deceases with age(31) and therefore a comparison of outcome on the cognitive tests before and after surgery needs to be corrected for the age-dependent change in outcome which is to be expected. The RFFT has already been submitted to a large control population comparable in age to the study population (the PREVEND-study: Prevention of REnal and Vascular ENd-stage Disease). Data on performance of the Trailmaking test are also available for the general population which allow comparison. References: (26) Ruff R. Ruff Figural Fluency Test: Professional Manual. Lutz, Florida: Psychological Assessment Resources Inc.; 1996. (27) Mulder J, Dekker P, Dekker R. Woord-Fluency Test (WFT) Figuur-Fluency Test (FFT) Handleiding. Leiden: PETS BV; 2006. (28) Reitan RM. The relation of the trail making test to organic brain damage. J Consult Psychol 1955 Oct;19(5):393-394. (29) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are: delirium (using the DOS), one-year mortality, morbidity up to 30 days postoperatively (using the Clavien-Dindo classification of morbidity(32)), physical performance status and quality of life (assessed by the SF-36(33)). Physical performance status will be assessed by the ADL and IADL questionnaires, the handgrip strength(34,35) and the TUG(36). The handgrip strength will be measured using a Jamar digital handgrip dynamometer. The TUG measures the time a person needs to get out of a chair, walk 6 meters and sit down again. The tests will be submitted at the most 1 month preoperatively and at discharge (or a maximum of 2 weeks postoperatively) and 3 months and 1 year postoperatively. References: (32) Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 2009 Aug;250(2):187-196. (33) Acree LS, Longfors J, Fjeldstad AS, Fjeldstad C, Schank B, Nickel KJ, et al. Physical activity is related to quality of life in older adults. Health Qual Life Outcomes 2006 Jun 30;4:37. (34) Giampaoli S, Ferrucci L, Cecchi F, Lo Noce C, Poce A, Dima F, et al. Hand-grip strength predicts incident disability in non-disabled older men. Age Ageing 1999 May;28(3):283-288. (35) Guo CB, Zhang W, Ma DQ, Zhang KH, Huang JQ. Hand grip strength: an indicator of nutritional state and the mix of postoperative complications in patients with oral and maxillofacial cancers. Br J Oral Maxillofac Surg 1996 Aug;34(4):325-327. (36) Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991 Feb;39(2):142-148. | — |
Countries
Netherlands
Outcome results
None listed