This study will be performed to test the predictive value of the GFI, the VES-13 and the timed *up and go* test compared to components of PACE in elderly patients of the age of 70 years and above undergoing surgery for a solid tumour.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be 30 day morbidity and mortality.
Secondary outcome
Secondary endpoints will be length of hospital stay and the number of
additional specialists involved in patient care in the 30 days after surgery.
Background summary
The majority of patients undergoing surgery for a solid tumour are over the age
of 701. About 30% of these patients can be considered frail. They have
comorbidities and are at a higher risk of developing postoperative
complications and experience functional loss. So far there is no simple
screening tool that allows the treating physician to identify those patients
most at risk of developing postoperative problems. Identifying those at risk is
a first step in the process towards preventing unnecessary postoperative
complications such as delirium, cardiovascular complications and overall
functional loss leading to loss of independency.
Several tools have been shown to be promising in this respect. The Preoperative
Assessment of Cancer in the Elderly (PACE) has been shown to be predictive of
30 day morbidity2. Poor health in relation to disability assessed using the
Instrumental Activities of Daily Living (IADL), fatigue and performance status
(PS) were associated with a 50% increase in the relative risk of postoperative
complications. Multivariate analysis identified moderate/severe fatigue, a
dependent IADL and an abnormal PS as the most important independent predictors
of post-surgical complications. Disability assessed by Activities of Daily
Living (ADL), IADL and PS were associated with an extended hospital stay
Study objective
This study will be performed to test the predictive value of the GFI, the
VES-13 and the timed *up and go* test compared to components of PACE in
elderly patients of the age of 70 years and above undergoing surgery for a
solid tumour.
Study design
This is a multi-centre prospective cohort study collecting descriptive data
across international centres for patients aged >70 years who are candidate to
undergo elective cancer surgery.Patients will be stratified according to tumour
localisation: intra cavity (e.g. colorectal, gynaecological) vs superficial
(e.g. breast, head & neck, melanoma).
The combination of components of PACE, the timed *up and go* test, the VES-13
and the GFI will be administered to every patient within two weeks prior to the
surgical procedure
Study burden and risks
There are no known risks or benefits associated with participation. The patient
will be required to answer some questions and walk a few meters which will take
a total of approximately 30 minutes.
Albinusdreef 2
2300 RC Leiden
Nederland
Albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
aged > 70 years, elective surgical cancer treatment, under general anesthesia,
give written inforemd consent
Exclusion criteria
patients requiring emergency surgical management within 24 hours
unable to give written informed consent
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 |
|---|---|
| Other | 4635 |
| CCMO | NL25936.058.08 |