Our primary aim is to tackle the factors of frailty in an early phase, which is possible in elective planned surgery. We hypothesise that optimal preparation, starting 5 weeks before surgery, will reduce the incidence of delirium from 15 % to 7.5…
ID
Source
Brief title
Condition
- Deliria (incl confusion)
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main outcome is the incidence of delirium measured by DOS scores, it's
duration and severity.
Also the mortality within one year.
Secondary outcome
Secondary we will investigate post operative complications and length of
hospital stay.
Pre operative Factors of frailty will be analysed, age, gender, co morbidity,
surgical history, medication use, home situation.
per-operative characteristics e.g. kind of anesthesia, duration of surgery,
complications during surgery, bloodloss.
post operatieve characteristics e.g. ICU admission, duration ICU and
complications.
Background summary
TThe population of people above 65 years old is expected to double in the next
35 years. The increase of age is associated with an increase in need for
medical care and number of patients requiring surgery. A higher rate of post *
operative complications, like a delirium (37%), longer hospital stay, ICU
admission, and mortality is associated with increasing age.
In our hospital, within the population of 70 years or older, approximately 85
patients per year undergo surgery for colorectal cancer and about 50 patients a
year undergo surgery for abdominal aortic aneurysm. We expect an increase in
the number these surgical procedures performed during the coming years (also
due to the implementation of screening programs).
A delirium is often a fatal disorder, which affects as much as 50 % of the
elderly people who are hospitalised. In this population, as described above,
the incidence of a delirium is about 15%. The 6-month mortality is increased
within patients with a postoperative delirium (20%) versus no delirium (3%).
[3]
In short a delirium is a common complication after surgical intervention and
results in a significant decrease in quality of life, an increased rate of
complications, mortality and additionally is associated with high costs.
Therefore a delirium holds essential health relevance.
Our goal is to anticipate on these factors of frailty in an early phase of
care, instead of at admission and to optimise patients during 5 weeks before
surgery, so less delirium, complications, hospital stay and mortality will
occur.
Study objective
Our primary aim is to tackle the factors of frailty in an early phase, which is
possible in elective planned surgery. We hypothesise that optimal preparation,
starting 5 weeks before surgery, will reduce the incidence of delirium from 15
% to 7.5 %.
Our secondary aim is to reduce post-operative complications, hospital stay, and
6 months mortality.
Study design
This study will be a prospective interventional study, (Intention to treat)
starting first of January 2016, till January 2018.
A clinical pathway is set up for all patients of seventy years or older with
surgical indication for colorectal cancer or abdominal aortic aneurysm, the
70PLUS outpatient clinic in our surgery department. Within one week after
confirming the indication for surgery, a nurse practitioner, a physiotherapist
and a dietician will see these patients and all factors of frailty will be
investigated. If needed, a geriatrician will also see the patient for complete
geriatric assessment and advice during admission to prevent delirium.
Diet advice and physical exercises will be given to all patients in need.
Patients must follow these advices and keep a diary.
Intervention
This study is set up as an outpatient clinical pathway in which we intervene in
the usual pathway till operation. Within one week after confirming the
indication for surgery patients will be seen. All factors of frailty will be
investigated. Questionnaires will be taken and physiotherapist will improve
patients physical condition, if needed refeeding or dietary advice will be
given. If needed a geriatrician will be consulted. If patient is anaemic iron
injection will be given.
factors that will be assesed and treated are:
1. dietician advice and/or refeeding
2. anaemia
3. physical condition
4. home evaluation for postoperative care
5. screening and prevention for delirium
6. quality of life
Study burden and risks
A clinical pathway is set up for all patiënt of 70 or older with surgical
indication for either colorectal cancer or abdominal aortic aneurysm, the 70
PLUS outpatient clinic in our surgery department. At the outpatient clinical
pathway (T1) we will assess all base line patient characteristics and
questionnaires will be taken. All patients will visit the physiotherapist, to
assess patients* condition. If needed dietician will be consulted or
geriatrician. A total of 3 hours (including consultation of dietician and
geriatrician) is needed for each patient.
If needed (in case this is not done during work up) blood is drawn for baseline
results,to assess aneamia, nutritional status and renal function.
At hospital admission (T2) patients will be seen by the same physiotherapist.
Also the same lab results will be measured.
At discharge (T3) patients will fill in questionnaires and blood wil be drawn.
At follow up after six months (T4) and 12 months (T5) questionnaires will be
taken.
In total we anticipated about 5 hours of extra time needed next to usual care
given.
Due to i.v. Iron injection , allergic reaction can occur. This product is used
normally for anaemic patients with iron deficiency. In-hospital protocol is
already in use and no other or adjuvant extra care will be undertaken. Addendum
describes the in-hospital protocol for the use of i.v. iron injection.
Due to physical exercises patient can fall. Usual care will be given.
We anticipated that no other risk is associatied with participation.
Molengracht 21
Breda 4818 CK
NL
Molengracht 21
Breda 4818 CK
NL
Listed location countries
Age
Inclusion criteria
Patient must be 70 years of age or older
Primairy abdominal surgical intervention due to colorectal cancer or abdominal aneurysm
Exclusion criteria
Patients who are operated on within one year after earlier abdominal surgery
Patient with dementia or not capable to fill in a questionform (e.g. language barrier)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL55694.101.15 |
OMON | NL-OMON25815 |
OMON | NL-OMON23625 |