Post-operative insulin resistance Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants are allocated to one of two groups:
1. Group one (control) receives the current pre-operative carbohydrate solution, Preload® (a maltodextrin solution). The Preload® group
Sponsors
East Lancashire Healthcare Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients >18 years 2. Laparoscopic colorectal resection 3. Included in Enhanced Recovery Protocol 4. American Society of Anesthesiologists (ASA) Physical Status classification 1-3 5. Able to give consent
Exclusion criteria
Exclusion criteria: 1. Non-English speaker 2. Pregnancy 3. Diagnosed diabetes mellitus (diet, drug or insulin controlled). 4. Diagnosed impaired glucose tolerance (fasting glucose in POAC >5.5 mmol/l and/or HbA1C>5.7%) 5. Decreased gastrointestinal motility (from medication or disease) or predisposition to reflux 6. Diagnosis of inflammatory bowel disease 7. Allergy to either preoperative carbohydrate drink
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin resistance from baseline on postoperative day 1 (POD 1) measured by Homeostasis Model Assessment (HOMA), which utilises serial fasting blood glucose and insulin measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in insulin resistance from baseline on POD 2 and POD 3 measured using HOMA 2. Stress response following surgery, measured by sampling cortisol levels preoperatively, at the end of surgery, and at 24 hours post-operatively and the inflammatory response measured by CRP levels pre-operatively, and on POD 1,2 and 3. 3. Ultrasound measurement of gastric volume pre-operatively 4. Recovery profile including: 4.1. PQRS score measured pre-operatively, at 2 hours after surgery, POD 3 and POD 7. 4.2. Muscle strength measured using a grip strength dynamometer pre-operatively, twice daily (morning and afternoon) on POD 1, 2 and 3, and then once daily on alternate days thereafter until discharge (the patient’s dominant hand will be used for this measurement, and the best out of three consecutive strengths will be used with mean values analysed). 4.3. Time to surgical fitness for discharge measured in hours (date and time of fitness for surgical discharge is recorded in the ERP database). Morbidity measured using the POMS score on POD 2 and 5. 4.4. PONV VAS score on POD 1. 5. Sensations of thirst & hunger Visual Analogue Scale (VAS) score immediately pre-operatively and on POD 1. 6. Adverse events i.e. aspiration and hypo- or hyperglycaemia (these are the only relevant safety assessments for these interventions) will be assessed on the operative day for the former & up to the end of POD 1 for the latter. 7. Cost analysis: difference in cost between doses of Pre-Load & Generation UCAN and costs of respective hospital and critical care lengths of stay. | — |
Countries
England, United Kingdom
Contacts
Public ContactAnton Krige
Outcome results
None listed