Table 1 Definitions of the primary endpoint.

Complications

   Intra-abdominal abscess

Fever and/or elevated CRP/WBC and intra-abdominal fluid collection on CT-imaging or ultrasound.

   Biliary injury

All injuries of the intra- and extrahepatic biliary ducts including leakage of the biliary tree*.

   Bleeding

Drop in haemoglobin level requiring transfusion and/or reintervention.

   Pneumonia

Coughing or dyspnoea, radiography with infiltrative abnormalities, elevated infection parameters and positive sputum culture.

   Myocardial infarction

Symptomatic elevated cardiac enzymes and abnormalities on electrocardiography or cardiac ultrasound.

   Cerebrovascular

(Temporary) loss of function of any body part or sense caused by cerebral ischemia or bleeding, proven on cerebral CT imaging.

   Thrombo-embolic

Symptomatic deep venous thrombosis or pulmonary embolism, radiologically proven.

Need for re-intervention

Relaparoscopy, laparotomy, ERCP, intervention radiology, readmission

Mortality