Optimising the Care and Treatment Pathways for Older Patients Facing Major Gastrointestinal Surgery.

NCT04545125 | Unknown

• 1 other identifier: STH20694
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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. 1.Whether patients who have poor outcomes after surgery can be identified at the start of their surgical journey
2. 2.Whether there are specific patient characteristics that are associated with whether individual patients undergo major surgery or not.
3. 3.What patients feel about different support measures that may be put in place to try to improve outcomes

Conditions

Old Age; Debility; Gastro-Intestinal Disorder

Outcome Measures

Primary Outcomes (1)

• Functional recovery at 6 weeks post-operation/ definitive procedure or from decision not to operate

  World Health Organisation Disability Assessment Schedule (WHO DAS). This is scored from 0 to 48 and then converted into a percentage. Minimum score 0%, maximum score 100%. Higher scores denote more disabled. "Disabled" classified as a score of 25% or higher. A change of 8% or more from baseline is defined as a new disability.

  6 weeks

Secondary Outcomes (4)

• Health related quality of life

  6 weeks

• Length of hospital stay

  From day 0 (hospital admission) to discharge from hospital (on average 6 days)

• Treatment related adverse events

  From day 0 (treatment) to discharge from hospital (on average 6 days)

• Survival

  6 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older patients with GI pathology amenable to surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator
• Sheffield Hallam University: collaborator

Study Sites (2)

Sheffield Teaching Hospitals NHS FT

Sheffield, Yorkshire, S5 7AU, United Kingdom

RECRUITING

Barnsley Hospital NHS FT

Barnsley, S75 2EP, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 33638249 DERIVED

MeSH Terms

Conditions

Frailty; Digestive System Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Daniels

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mod Harris

CONTACT

0114 2713570; modhumita.harris@nhs.net

Debby Hawkins

CONTACT

0114 2266210; debby.hawkins@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 10, 2020
• Study Start: August 18, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: January 7, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)