Clinical trial NCT04545125: Optimising the Care and Treatment Pathways for Older Patients Facing Major Gastrointestinal Surgery.
Official title: Optimising the Care and Treatment Pathways for Older Patients Facing Major Gastrointestinal Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Old Age; Debility
Gastro-Intestinal Disorder
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: Sheffield Hallam University
First posted: 2020-09-10
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients with GI pathology amenable to surgery

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 65+ years old inclusive
* Patients with a diagnosis of gastrointestinal pathology amenable to elective, urgent (unscheduled) or emergency major gastrointestinal surgery who either undergo surgery, a risk-adapted procedure or are managed conservatively (due to patient wishes, co-morbidities or frailty).
* Mental capacity to consent

Exclusion Criteria:

* Patients aged less than 65 years old
* Patients with unresectable disease (location, invasion, dissemination)
* Lack mental capacity to consent
* Unable to understand the information provided (translational issues)
* Prisoners
* Patients undergoing surgery for major trauma
* Patients undergoing surgery for primary gynaecological, vascular or urological disease

Primary outcomes:
measure: Functional recovery at 6 weeks post-operation/ definitive procedure or from decision not to operate
timeFrame: 6 weeks
Secondary outcomes:
measure: Health related quality of life
timeFrame: 6 weeks
measure: Length of hospital stay
timeFrame: From day 0 (hospital admission) to discharge from hospital (on average 6 days)
measure: Treatment related adverse events
timeFrame: From day 0 (treatment) to discharge from hospital (on average 6 days)
measure: Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS FT
state: Yorkshire
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS FT
Study officials:
affiliation: Sheffield Teaching Hospitals NHS FT
name: Sarah Daniels
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daniels SL, Lee MJ, Moug S, Wilson TR, Burton M, George J, Brown SR, Wyld L. Protocol for a multi-centre observational and mixed methods pilot study to identify factors predictive of poor functional recovery after major gastrointestinal surgery and strategies to enhance uptake of perioperative optimization: Optimizing the care and treatment pathways for older patients facing major gastrointestinal surgery (OCTAGON). Colorectal Dis. 2021 Jun;23(6):1552-1561. doi: 10.1111/codi.15603. Epub 2021 Mar 22.