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| ID | Type | Description | Link |
|---|---|---|---|
| 07/H0716/55 | Other Identifier | NHNN REC Number | |
| PB-PG-0906-11426 | Other Grant/Funding Number | UK National Institute of Health Research (NIHR) |
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| Name | Class |
|---|---|
| University Hospital Southampton NHS Foundation Trust | OTHER |
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The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in guiding the care pathway of patients undergoing colorectal operations. In the intervention group care will be guided by CPX results and in the control group care will be guided by the doctors assessment. The investigators would like to assess the impact of this on patient outcome, patient satisfaction and resource usage.
Each year 20000 UK patients die within 30 days of surgery. It seems that in the UK a patient's chances of becoming seriously unwell or dying following surgery is higher than in comparable countries. Fewer beds in the UK are given over to Intensive Care than in these other countries. Closer attention to the care given after operations, which can be achieved on intensive care units (ICU), almost certainly reduces the chances of serious illness following major surgery. An increase in the number of intensive care unit beds in the UK is extremely unlikely. Better use of the available intensive care beds could be achieved by allocating them where they are believed to improve outcome (following surgery) and by allocating them to patients most likely to benefit.
Tests used to assess risk of surgery to patients are largely ineffective. Cardiopulmonary exercise tests (CPX) seem to be effective at identifying patients at risk of death or serious illness post surgery. This information has been used in studies to select patients for ICU beds and reduce deaths. The studies so far have limitations in their design and scope which means we can't be certain this approach works in the UK.
We suggest a study to answer this question more conclusively and more specifically in UK patients. We will randomly divide patients between two groups. In the 1st group choice of postoperative care environment is based on best current practice and in the other group we will make these decisions (critical care or ward) based on the results of the CPX.
We hope that the benefits will include less patients becoming seriously ill or dying and shorter stays in hospital after surgery following major operations. We also hope the information will help patients understand the risks of their operation better and therefore make better informed decisions. This may also reduce the overall cost of surgery for hospitals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care) |
|
| B | Experimental | Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold & ventilatory equivalents |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative care pathway guided by CPX results | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity (presence or absence of POMS defined morbidity) | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary | Day 5 | |
| Total postoperative ITU bed utilisation | End of hospital stay i.e. day of hospital discharge | |
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Inclusion Criteria:
Exclusion Criteria:
Age < 18 years age
Patient unwilling/unable to consent
Adults with learning disabilities or dementia
Prisoners
Any contraindication to cardiopulmonary exercise testing (as outlined by *American Association of Anaesthesia:
Patients already enrolled in an interventional study
Previous CPX test result recorded in the medical notes
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| Name | Affiliation | Role |
|---|---|---|
| Michael PW Grocott | University College, London | Study Director |
| Paula Meale | University College, London | Principal Investigator |
| Michael Mythen | University College, London | Principal Investigator |
| Ayo Oshowo | Whittington Hospital NHS Trust | Principal Investigator |
| Mervyn Singer | University College, London | Principal Investigator |
| Geoff Bellingan | University College London Hospitals | Principal Investigator |
| Kay Mitchell | University College, London | Principal Investigator |
| Hasan Muktar | The Whittington Hospital Hospital NHS Trust | Principal Investigator |
| Alistair Windsor | University College London Hospitals | Principal Investigator |
| Jim Down |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whittington Hospital NHS Trust | London | N19 5NF | United Kingdom | |||
| University College London Hospitals NHS Foundation Trust |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Total postoperative bed utilisation |
| End of hospital stay i.e. day of hospital discharge |
| ITU re-admission | End of hospital stay i.e. day of hospital discharge |
| Death | Should death occur |
| SF36 (compared with SF36 at baseline) | 12 months post day of surgery |
| University College London Hospitals |
| Principal Investigator |
| Martin B Kuper | Whittington Hospital NHS Trust | Principal Investigator |
| Denny ZH Levett | University College, London | Principal Investigator |
| Phil Hennis, PhD | UCL | Principal Investigator |
| Alasdair O'Doherty, MSc | UCL | Principal Investigator |
| Alec Engledow | UCLH | Principal Investigator |
| Aundrea Mulreany | Whittington Hospital | Principal Investigator |
| Carolyn Dr Way | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Karen Linford | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Clare Bolger | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Paul Nichols | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Kim Golder | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| John S Knight | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Michael Celinski | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Grace Adesina | University College London Hospitals | Principal Investigator |
| London |
| NW1 2BU |
| United Kingdom |
| Southampton University Hospitals NHS Trust | Southampton | United Kingdom |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |