To identify relevant geriatric assesment tests to develop a clinical instrument for predicting tolerance defined as the change of developing a complication in elderly patients (>=70 years) with a coloncarcinoma that recieve surgical treatment for…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study is morbidity, defined as complication rate.
Complications will be registered according to the Dutch Surgical Colorectal
Audit (DSCA), following the LHCR grading system. Both general as surgical
complications are included.
Secondary outcome
Secundary outcomes are: 30 day mortality, only surgical complications, only
general complications, complications requiring re-intervention, quality of life
3 months after surgery, in-hospital stay, stoma, discharge to the patients own
house or institution, and ADL dependency.
Background summary
In western countries (like the Netherlands) the number of people of advanced
age is rapidly increasing . Advanced age is associated with developing cancer.
In a relatively high percentage the malignancy is situated in the colon.
Elderly represent a very heterogeneous group. With increasing age,
physiological reserves decrease and people become more vulnerable to disease
and stress. However the pace of this declining process varies significantly
between individuals, therefore high age is an exclusion criterion for many
clinical trials. Little research is done in elderly cancer patients and little
is known about this growing patient group. In this modern age of targeted
therapy and individualized cancer care oncologists need objective and validated
clinical tools which can accurately discriminate between fit and frail elderly
patients to determine which patients will tolerate surgical treatment.
Study objective
To identify relevant geriatric assesment tests to develop a clinical instrument
for predicting tolerance defined as the change of developing a complication in
elderly patients (>=70 years) with a coloncarcinoma that recieve surgical
treatment for their illness.
Study design
We will perform a multicentre (St. Antonius Hospital, Nieuwegein,and Tergooi
Hospital Blaricum) prospective cohort study. To develop the predicting model,
validated geriatric questionares (for health and functioning) and short
mobility test (timed up and go test) derived from geriatric medicine will be
used. Patients will be asked to complete these test before surgery. Furthermore
3 months after surgery the quality of life questionnaires will be repeated.
Additional informtion will be derived from the patients charts. No additional
bloodsamples or other interventions will not take place.
Study burden and risks
it is expected that participation in this study will have no advantages or
disadventages for the patients. For completing the questionares two times a
time investment of 30 to 60 minutes will be necessary. The study will not
interfere with the treatment of any patient. There will be no interventions in
this study.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
-Patients with a coloncarcinoma that are eligble for surgery based on their illness.
-Patients aged 70 years or older at the date of surgery
-Operations that have the purpose to establisch a primary anastomosis or a (temporary) stoma.
-Laparoscopic and open surgeries
-informed consent.
Exclusion criteria
-Patients that are not capable to participate in the study because of poor understanding and speaking of the Dutch language
-Patients that are not capable to participate in the study because of cognitive impairment.
-Non elective surgery (meaning emergency surgery)
-If the predetermined purpose of the surgery is debulking and not resection.
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 | NL42269.100.12 |