In this pilot study experience will be obtained in diagnosing POCD and its risk factors, in elderly surgical cancer patients.
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of POCD defined by a postoperative change in cognitive function
measured by the Ruff Figural Fluency (RFFT) score and Trailmaking test (TMT)
score in comparison to the preoperatieve score. Secondary outcome measures are
Secondary outcome
memory (measured by the 15 words test) and daily functioning and quality of
life measured by the instruments in the "minimale dataset (MDS)". These tests
will be performed preoperatively and at discharge (or a maximum of 2 weeks
postoperatively) and 3 months postoperatively.
Background summary
Postoperative cognitive dysfunction (POCD) is a phenomenon that has an
enormous impact on the ability of elderly patients to function independently in
everyday life. In contrast to what is generally believed, the knowledge on the
incidence and impact of POCD on quality of life is very limited. It is
therefore of the utmost importance to establish the incidence of POCD including
its predictors.
Study objective
In this pilot study experience will be obtained in diagnosing POCD and its risk
factors, in elderly surgical cancer patients.
Study design
Observational study
Study burden and risks
The participating patients will have to complete 3 tests and 2 questionnaires
at inclusion in the study which will take about 60 minutes in total. At
discharge and 3 months postoperatively they will be asked to complete the same
set of tests and questionnaires. Blood and saliva samples will be taken
preoperatively and postoperatively to determine operative immuneresponse
measured by Interleukine-6 (Il-6) blood levels, and peroperative stress
measured by cortisol levels in saliva . A reference blood sample will be stored
for future analysis. These blood samples or the tests they are asked to
complete are not expected to cause an extra burden or discomfort to the
participating patients. No experimental drugs will be used during this study.
Hanzeplein 1
9300 RB
NL
Hanzeplein 1
9300 RB
NL
Listed location countries
Age
Inclusion criteria
Patients over 65 years of age admitted to the Department of Surgery of the University Center Groningen for the surgical or combined cancer treatment (surgery / radiation /chemotherapy / hormonal therapy) of a solid tumor will be included in this study. This will include patients undergoing surgery for a malignancy of the breast, thyroid, soft tissue, hepatobilliairy tract, colorectal tumors, and skin tumors• 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 psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.;• patient unable to comply with the outcome questionnaires
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 |
|---|---|
| CCMO | NL31486.042.10 |