Table 2

Standard definitions of complications for assessing morbidity of trial patients
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

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.

Kennedy et al.

Kennedy et al. BMC Cancer 2012 12:181   doi:10.1186/1471-2407-12-181

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