An interventional study of Perioperative care pathway guided by CPX results in Colorectal Cancer, Anaesthesia and Critical Illness, sponsored by University College London Hospitals. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-21.
Sponsored by University College London Hospitals · Not applicable, Interventional, and Treatment
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 228 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University College London Hospitals is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Any contraindication to cardiopulmonary exercise testing (as outlined by *American Association of Anaesthesia:
Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care)
Other: Perioperative care pathway guided by CPX results
Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold \& ventilatory equivalents
Other: Perioperative care pathway guided by CPX results
* AT \> 11ml/min/kg no myocardial ischaemia or Ve/VO2 \<35 - Level 1 Ward Care * AT \> 11ml/min/kg with myocardial ischaemia or Ve/VO2 \>35 - Level 2/3 (ITU) Critical Care Unit * AT \<11mls/min/kg - Level 2/3 Critical Care Unit * AT \<8mls/min/kg - Level 2/3 Critical Care Unit/ consider cancellation or alternative procedure
Postoperative morbidity (presence or absence of POMS defined morbidity)
Time frame: Day 5
Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary
Time frame: Day 5
Total postoperative ITU bed utilisation
Time frame: End of hospital stay i.e. day of hospital discharge
Total postoperative bed utilisation
Time frame: End of hospital stay i.e. day of hospital discharge
ITU re-admission
Time frame: End of hospital stay i.e. day of hospital discharge
Death
Time frame: Should death occur
SF36 (compared with SF36 at baseline)
Time frame: 12 months post day of surgery
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University College London Hospitals