Table 1.

Definitions of primary endpoints

Endpoint	Definition	Comment
Death		Within one year after randomisation
Major complications:
Intra-abdominal abscess	Fever or increased C reactive protein level/white blood cell count, or both, and intra-abdominal fluid collection on computed tomography or ultrasonography	Within 30 days after randomisation
Pneumonia	Coughing or dyspnoea, radiography with infiltrative abnormalities, increased infection variable, and positive sputum culture result	Within 30 days after randomisation
Myocardial infarction	Symptomatic increased cardiac enzyme levels and abnormalities on electrocardiography or cardiac ultrasonography	Within 30 days after randomisation
Pulmonary embolism	Radiologically proven pulmonary embolism	Within 30 days after randomisation
Need for reintervention	Surgical, endoscopic, or radiological reintervention	Within one year after randomisation. Before analysis, the adjudication committee decided to only report reinterventions directly or indirectly related to acute cholecystitis. A routine elective cholecystectomy after percutaneous catheter drainage was not included in the primary endpoint (ie, only cholecystectomies for recurrent gallstone related complications were included)
Recurrent biliary disease		Within one year after randomisation. Before analysis, the adjudication committee decided to only report recurrent biliary disease when readmission was required