Skip to main content

Table 1 Definitions of the primary endpoint.

From: Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

Endpoint Definition
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  
  1. CRP - C-Reactive Protein; WBC - White Blood Cell count; CT - computed Tomography; ERCP - Endoscopic Retrograde Cholangiopancreaticography
  2. * Type A: leakage of the minor hepatic ducts or cystic duct. Type B: leakage of common bile duct (CBD) without stricture - Type C: stricture of the CBD without bile leakage - Type D: complete transection of the CBD with or without resection of a part of it [11].
\