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Table 2 Standard definitions of complications for assessing morbidity of trial patients

From: EnROL: A multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme

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
  1. Major morbidity is defined as any of the following occuring within the hospital admission or 30 days of surgery: haemorrhage (requiring transfusion), any re-operation or readmission, anastomotic leakage, wound dehiscence, sepsis requiring at least high dependency support, HDU stay of > 5 days, unplanned admission to Intensive or Coronary Care Unit and death.