Old Age; DebilityOCTAGONNCT04545125
Optimising the Care and Treatment Pathways for Older Patients Facing Major Gastrointestinal Surgery.
An observational study of Old Age; Debility and Gastro-Intestinal Disorder, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age; Debility, Gastro-Intestinal Disorder
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Aug 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older patients with GI pathology amenable to surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Barnsley Hospital NHS FT
Barnsley, S75 2EP
Michael Shanaghey
- Recruiting
Sheffield Teaching Hospitals NHS FT
Sheffield, Yorkshire, S5 7AU
Sarah Daniels, sarahdaniels1@nhs.net
Debby Hawkins, debby.hawkins@nhs.net
About this study
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).
Read more
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:
- Whether patients who have poor outcomes after surgery can be identified at the start of their surgical journey
- Whether there are specific patient characteristics that are associated with whether individual patients undergo major surgery or not.
- What patients feel about different support measures that may be put in place to try to improve outcomes
Read the 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.
- Conditions
- Old Age; Debility, Gastro-Intestinal Disorder
- Medical subject headings
- Frailty, Digestive System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
Health related quality of life
EQ-5D-5L Visual analogue scale (VAS) will be used for statistical analysis which is a scale from 0 to 100 with 0 being the worst health you can imagine and 100 being the best health you can imagine. Baseline score will be compared to post-operative score.
Measured: 6 weeks
Length of hospital stay
The number of days from hospital admission (day 0) to discharge from hospital (on average 6 days)
Measured: From day 0 (hospital admission) to discharge from hospital (on average 6 days)
Treatment related adverse events
Reporting the type and grade of adverse event relating to the treatment. The AE will be graded using the Clavien-Dindo Classification system (grades I-IV), grade IV being the most severe.
Measured: From day 0 (treatment) to discharge from hospital (on average 6 days)
Survival
Any death 6 months from index procedure or decision
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start18 Aug 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, Sheffield Hallam University
- Responsible party
- Sponsor
- Investigators
- Sarah Daniels, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545125
- Sponsor's protocol ID
- STH20694
- Acronym
- OCTAGON
- Status last verified
- Sep 2020
- First submitted
- 24 Aug 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33638249
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising the Care and Treatment Pathways for Older Patients Facing Major Gastrointestinal Surgery.
- ClinicalTrials.gov ID
- NCT04545125
- Acronym / sponsor ID
- OCTAGON / STH20694
- Conditions
- Old Age; Debility, Gastro-Intestinal Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, Sheffield Hallam University
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether patients who have poor outcomes after surgery can be identified at the start of their surgical journey
- Whether there are specific patient characteristics that are associated with whether individual patients undergo major surgery or not.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients with GI pathology amenable to surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional recovery at 6 weeks post-operation/ definitive procedure or from decision not to operate
Time frame: 6 weeks
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.
4 secondary outcomes
Health related quality of life
Time frame: 6 weeks
Length of hospital stay
Time frame: From day 0 (hospital admission) to discharge from hospital (on average 6 days)
Treatment related adverse events
Time frame: From day 0 (treatment) to discharge from hospital (on average 6 days)
Survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Derived from this study: PubMed 33638249Daniels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Daniels principal investigator
Sheffield Teaching Hospitals NHS FT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Old Age; Debility and Gastro-Intestinal Disorder, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mod Harris (0114 2713570 ext. 13570, modhumita.harris@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery at 6 weeks post-operation/ definitive procedure or from decision not to operate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.