Elective major colorectal surgery Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both males and females, age 18 and older 2. Elective colorectal surgical patients scheduled for major surgery 3. Patients with a measurable anaerobic threshold (AT) above 8 ml O2/kg/min
Exclusion criteria
Exclusion criteria: Absolute: 1. Unwillingness to participate 2. Inability to perform the tests and consent within the timetable for elective surgery 3. Measured Anaerobic Threshold below 8 ml O2/kg/min. Such patients will be considered to be extremely unfit and as such will not be suitable for inclusion in the trial. 4. Withdrawn by anaesthetist or surgeon 5. Acute myocardial infarction (3?5 days) 6. Unstable angina 7. Uncontrolled arrhythmias causing symptoms or haemodynamic compromise 8. Syncope 9. Active endocarditis 10. Acute myocarditis or pericarditis 11. Symptomatic severe aortic stenosis 12. Uncontrolled heart failure 13. Acute pulmonary embolus or pulmonary infarction 14. Thrombosis of lower extremities 15. Suspected dissecting aneurysm 16. Uncontrolled asthma 17. Pulmonary edema 18. Room air desaturation at rest <85% 19. Respiratory failure 20. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis) 21. Severe oesophageal disease 22. Recent oesophageal or upper airway surgery 23. Systemic steroid medication 24. Bleeding diathesis Relative: 25. Left main coronary stenosis or its equivalent 26. Moderate stenotic valvular heart disease 27. Severe untreated arterial hypertension at rest (200 mm Hg systolic, 120 mm Hg diastolic) 28. Tachyarrhythmias or bradyarrhythmias 29. High-degree atrioventricular block 30. Hypertrophic cardiomyopathy 31. Significant pulmonary hypertension 32. Advanced or complicated pregnancy 33. Electrolyte abnormalities 34. Orthopaedic impairment that compromises exercise performance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amongst patients having major elective colorectal surgery under an Enhanced Recovery after Surgery (ERAS) pathway: 1. Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in patients who are categorised ?high risk? on the basis of a preoperative cardiopulmonary exercise test result? 2. Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in patients who are categorised ?standard risk? on the basis of a preoperative cardiopulmonary exercise test result? 3. Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in all patients? | — |
Secondary
| Measure | Time frame |
|---|---|
| Amongst patients having major elective colorectal surgery under an ERAS pathway, does intraoperative goal directed fluid therapy make a difference to the following when compared with standard therapy alone?: 1. Peri-operative mortality (30 days) 2. Postoperative hypotension 3. Postoperative fluid requirement 4. Return of gastrointestinal function 5. Tolerance of diet Secondary outcomes 2-5 will be assessed every post-op day until the participants meet discharge criteria (median length of stay for this surgery is currently 9 days [as of 17/02/2009]). | — |
Countries
United Kingdom