The main objective of this study is to identify the incidence of POCD in adult patients under 50 years of age, who undergo major surgery
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of postoperative cognitive decline (POCD) at 4 weeks after
surgery.
Secondary outcome
- The incidence of POCD on the day of discharge.
- The relation between POCD and baseline characteristics (e.g. age, educational
level, diabetes, hypertension, use of medication).
- A comparison of the incidence of POCD in the patients undergoing general or
regional anaesthesia.
Background summary
In the past 10-15 years, multiple studies have shown that postoperative
cognitive decline (POCD) is evident in elderly patients (>60 years). Following
cardiac surgery, cognitive dysfunction is a clinically relevant health hazard
that occurs in up to 30% of patients. The incidence of POCD after non-cardiac
surgery is slightly lower, but it still occurs in a considerable percentage of
this rather large group of patients.
Although several studies indicate that in the longer term most patients fully
recover from POCD, cognitive decline in the early postoperative period can have
a considerable effect on patient quality of life, with increased health service
demands. Also, in terms of economics, delayed return to employment is an
important *side-effect* of (even short lasting) POCD, which is particularly an
issue in younger patients.
Until date, however, very little is known about the incidence of POCD in
younger patients (<40 years old). In this study, we will therefore investigate
the incidence of postoperative cognitive decline in patients aged 18-50 years.
Study objective
The main objective of this study is to identify the incidence of POCD in adult
patients under 50 years of age, who undergo major surgery
Study design
This study is designed as an observational cohort study. Cognitive performance
of eligible patients will be compared before and after the operation. To
control for learning effects and natural fluctuations in testing performance,
the patients* test results will be compared to results of a group of healthy
control subjects, who will be matched for age and educational level.
Study burden and risks
The patient burden for this study consists of 3 computerized cognitive tests.
The first one will be during the preoperatieve screening visit; the other two
at discharge and 4 weeks after the procedure, respectively. Per test, around 15
minutes are required.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
patient is 18- 50 years old
patient is undergoing elective major surgery
patient is living in the city of Utrecht
Exclusion criteria
patient is younger than 18 years or older than 50 years
patient is undergoing cardiac surgery
patient is undergoing neurosurgery
patient is undergoing emotional encumbering procedure
patient is suffering from a psychiatric disorder
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 | NL12062.041.06 |