Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04545125 |
| Other study ID # |
STH20694 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 18, 2020 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
September 2020 |
| Source |
Sheffield Teaching Hospitals NHS Foundation Trust |
| Contact |
Mod Harris |
| Phone |
0114 2713570 |
| Email |
modhumita.harris[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The UK population is ageing. Whilst many people remain active and in good health as they get
older, getting older is associated with the onset of many common medical conditions, as well
as memory and mobility problems. There is a natural decline in heart and lung fitness with
age, although this may be slowed by regular exercise and physical activity. The majority of
digestive system problems that require operations (such as bowel cancer) are more common in
older people. These operations can reduce an older person's ability to look after themselves
and their quality of life. In some cases there is a trade-off between major surgery and a
smaller operation or procedure with a lower chance of cure, but a faster rate of recovery and
fewer problems immediately after the procedure. (Examples of smaller operations include
bringing the bowel out onto the abdominal wall; creating a 'stoma'. Examples of procedures
include inserting a tube inside the bowel or oesophagus to open up a blockage; insertion of a
'stent'). Some patients may be advised or may choose not to undergo any form of treatment.
Deciding whether a person is fit enough to undergo a major operation is difficult and depends
on patient factors (e.g. heart and lung fitness, other medical conditions, patient choice)
and technical factors (location and spread of disease, availability of other options for
treatment).
In the outpatient setting there are a number of tests that can be used to try to work out
what the risks of a major operation will be for a particular person. These can then guide
different approaches to try to lessen these risks. Examples include exercise programmes,
dietary supplements and anxiety management programmes in the period before the operation. In
the emergency setting there is often not sufficient time before their operation but there are
still a number of ways of improving the chances of a good recovery, such as meeting with a
physiotherapist and early planning for discharge needs.
This study aims to explore:
1. Whether patients who have poor outcomes after surgery can be identified at the start of
their surgical journey
2. Whether there are specific patient characteristics that are associated with whether
individual patients undergo major surgery or not.
3. What patients feel about different support measures that may be put in place to try to
improve outcomes
Description:
The UK population is aging. Under-investigation and under-treatment of older people is
common, with rates of surgery declining with age, despite the incidence of surgically treated
gastrointestinal pathology increasing with age. There are large variations in outcomes in
older people, between different surgical units in the UK, which suggests that not all
patients are receiving the same level of care or access to resources. In GI surgery, the
concern is that patients in centres with low elective surgery rates will be inappropriately
denied the benefits of operative intervention (disease control, symptom improvement), with
consequently higher rates of emergency admission and intervention. Conversely, in centres
with high rates of elective surgery, patients may be inappropriately subjected to the
morbidity or even mortality of surgery with limited or no benefit.
Major surgery remains one of the most debilitating events that an older person may experience
and may profoundly influence functional decline and disability. Optimisation of outcomes in
older patients with comorbidities and frailty requires multi-professional input which is
often lacking. Adverse factors associated with ageing include co-morbidity, polypharmacy,
cognitive impairment, dependency and frailty, all of which are associated with increased all
cause mortality in the general population. There is also a natural decline in
cardiorespiratory fitness with age, however this may be modifiable with physical activity or
exercise. Malnutrition and psychological problems are also very common in patients requiring
gastrointestinal surgery. When these at-risk individuals are exposed to the stress of major
abdominal surgery, post-operative mortality and morbidity also increase. Common lifestyle
choices, including smoking, excess alcohol consumption and sedentary behaviours, add to this
risk.
