Background
Methods/design
Study design
Randomisation
Intervention
Blinding
Enhanced recovery care
Before admission | Conditioning of expectations of patient and carer by receipt of oral and written information at a dedicated preadmission visit, or by telephone counselling, with provision of a dedicated booklet or video sent by post. | |
Meeting with stoma nurse if stoma anticipated. | ||
Identification of factors that might delay discharge and consideration of solutions e.g. provision of support when discharged if living alone. | ||
Co-morbid risk assessment: optimised pre-morbid health status. | ||
Day before surgery | Avoidance of oral bowel preparation except in patients undergoing total mesorectal excision (TME) and reconstruction. | |
Nutrition: three high protein/high calorie drinks if receiving oral bowel preparation. | ||
Day of surgery | Pre-operatively | Preoperative oral carbohydrate loading to be given 2-4 hours prior to anaesthesia, using 200ml of fluid containing 12.5g/100ml CHO with a proven safety profile. |
Avoidance of long acting sedative medication from midnight prior to surgery. | ||
In theatre | Activation of thoracic epidural (T6-11) prior to skin incision. | |
Avoidance of abdominal drains at primary operation. | ||
Avoidance of nasogastric drainage in the immediate postoperative period. | ||
Total volume of IV fluid < 3000ml. | ||
The use of upper body forced air heating intraoperatively. | ||
Local anaesthetic infiltration to the largest wound in minimal access surgery. | ||
Open surgery: small transverse or curved incisions when possible. | ||
After theatre | Oral intake of ≥ 800ml fluid (including oral nutritional supplements) postoperatively on the day of surgery, before midnight. | |
≥ 200ml oral nutritional supplement postoperatively on the day of surgery, before midnight. | ||
Mobilisation by walking or sitting in a chair. | ||
First Postoperative day from midnight – midnight (Day 1) | ≥ 2 units of oral nutritional supplement taken. | |
Termination of IV fluid infusion. | ||
Intake and tolerance of solid food. | ||
Intake of lactulose or a magnesium preparation to enhance bowel movements. | ||
Use of thoracic epidural analgesia. | ||
Mobilisation (out of bed) for at least 6 hours. | ||
Provided patient mobile, termination of urinary drainage on day 1, except after TME when it may be preferable to leave it until day 3 | ||
Assisted mobilisation – 4 × 60m walks. | ||
Second Postoperative day from midnight – midnight (Day 2) | Pain relief: termination of the thoracic epidural analgesia. | |
Use of a multi-modal analgesic regime at, or before, discontinuation of thoracic epidural analgesia e.g. paracetamol and non steroidal anti-inflammatory or equivalent. | ||
Termination of urinary drainage on day 2 or earlier, except after TME when it may be preferable to leave it until day 3. | ||
Discharge | Aim for discharge day 2-3 for colonic and proximal rectal resection; day 5 when a stoma fashioned. | |
Discharge Criteria: patients must be tolerating normal food, mobilising independently and be managed on oral analgesics to fulfil discharge criteria. | ||
Follow up: provision of hospital contact numbers to allow discussion of problems; expedited review on ward if problems within 2 weeks of surgery. | ||
Review in out patient clinic at two weeks post operation. |
Measurement of outcomes
Primary endpoint
Secondary endpoints
Postoperative hospital stay
Complications, re-admission, re-operation and mortality rates
Category | Definition |
---|---|
Cardiorespiratory | Respiratory failure - requiring mechanical ventilation |
Cardiac failure: cardiac index < 2 litres per m2 (treated first by fluid resuscitation and if no response by inotropic or vasoconstrictive medication) | |
Pulmonary oedema - radiological diagnosis | |
Arrhythmia - ECG changes requiring medical treatment and/or electroconversion | |
Pleural fluid - radiographic diagnosis | |
Acute myocardial infarction - electrocardiographic diagnosis | |
Acute renal failure - requiring haemofiltration | |
Stroke with neurological symptoms | |
Pulmonary embolism | |
Distal ischaemia | |
Deep vein thrombosis - requiring duplex, radiological or other confirmation | |
Other cardiorespiratory | |
Surgical | Unexpected blood loss >0.5 litres during operation |
Bowel perforation | |
Ureteric damage | |
Wound dehiscence involving separation of deep abdominal wall closure | |
Postoperative bleeding - overt blood loss requiring > 2 litre transfusion with a normal clotting profile. | |
Delayed oral intake - intravenous fluids > 1 week owing to postoperative ileus | |
Bowel obstruction requiring reoperation | |
Anastomotic leakage defined within 30 days of surgery radiologically (demonstration on abdominal CT with oral contrast, MRI or by contrast enema), surgically (visual evidence of faecal leakage at reoperation) or at autopsy (presence of a disrupted anastomosis). | |
Necrosis of stoma - requiring surgery | |
Aspiration Pneumonia - radiological diagnosis with appropriate history | |
Other surgical | |
Infective | Sepsis - pyrexia > 38 oC, septic focus or positive blood culture |
Postoperative peritonitis - clinical diagnosis | |
Abdominal abscess - ultrasonograpy, computed tomography or operative diagnosis | |
Necrotising fasciitis | |
Wound infection - defined as any one of the following: (modified from reference 26) | |
1. Purulent discharge or the aspiration of pus | |
2. Erythema or localised swelling requiring antibiotics or surgical drainage, unless the drainage is clear and negative on culture i.e. a seroma | |
3. A diagnosis of a wound infection made by a doctor. | |
4. Report of wound discharge by the patient unless it is proven to be uninfected | |
Chest infection - radiological diagnosis or empyema | |
Urinary tract infection | |
Disseminated intravascular coagulation | |
Other infective complication |
Patient reported and functional outcomes
Questionnaire/Assessment | Data Collection Time Point | ||||
---|---|---|---|---|---|
Pre Operative* | Post-operative | ||||
4 weeks | 3 months | 6 months | 12 months | ||
MFI-20 | X | X | X | X | |
SF-36 | X | X | X | X | |
EQ-5D | X | X | X | X | |
Health Economics | X | X | X | X | |
Body Image | X | X | X | ||
SPIs | X | X | X | X |