Objective: The primary objective of this study is to show that early detection of geriatric patients at risk of preventable functional decline following a surgical procedure under general anesthesia for a solid tumor, combined with a geriatric…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main endpoint is the cumulative incidence
of delirium (measured with the Delirium Observation Scale and the DSM IV
criteria) up to 10 days postoperatively. Secondary endpoints are: returning to
the pre-operative living situation within 3 months postoperatively,the Physical
Component Summary measure (PCS) of the SF-36, the Mental Component Summary
measure (MCS) of the SF-36, complications during hospital stay including
mortality, care Dependence Scale at discharge. Direct health care and
non-health care costs will be used as economic indicators
Secondary outcome
see above
Background summary
Rationale: It has been shown that a multicomponent intervention can decrease
the occurrence of delirium in older patients (Inouye et al 1999). Geriatric
liaison teams are well trained in implementing best-supportive care programs
for elderly. In standard care geriatricians are not involved in pre-operative
screening of patients and perioperative care and will only be consulted after
major complications (delirium) or functional losses have occurred.
Study objective
Objective: The primary objective of this study is to show that early detection
of geriatric patients at risk of preventable functional decline following a
surgical procedure under general anesthesia for a solid tumor, combined with a
geriatric liaison intervention will decrease the occurrence of delirium and
consequent morbidity and mortality, without an increase in costs.
Study design
Study design: This is a multicenter prospective randomized clinical trial.
Intervention
Intervention: The intervention entails participation of a geriatric nurse and
geriatrician in the perioperative treatment of the oncogeriatric surgical
patient.
Study burden and risks
The participating patients will have to complete 2 questionnaires at inclusion
in the study which will take about 30 minutes in total. During their hospital
stay they will be asked to complete several questionnaires which will take 15
minutes daily on average. Also 3 months postoperatively they will be asked to
complete a questionnaire which takes 15-30 minutes on average. The Hb value
will be taken from the routine blood samples and no extra blood samples or
diagnostic tests will be performed on the participating patients unless their
medical condition requires this (e.g. to rule out dehydration). Although
changes in diet or medication may be made in the study group these are not
expected to cause an extra burden or discomfort to the participating patients.
No experimental drugs will be used during this study.
PO BOX 30001
9700RB Groningen
Nederland
PO BOX 30001
9700RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
frail elderly patients in need for a cancer operation
Exclusion criteria
unable to comply outcome questionaires
no compiance for follow-up
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 | NL15136.042.06 |