Study design and participants
gallstones, perforation, empyema, gallstone disease, sepsis, biliary colic
ACUTE CHOLECYSTITIS, GALLSTONES, CHOLEDOCHOLITHIASIS, HAEMOLYTIC DISEASE, SECONDARY, EMPYEMA, ACUTE PANCREATITIS, GALLSTONE DISEASE, OF GALLBLADDER CANCER, SEPSIS, BILIARY COLIC, OBSTRUCTIVE JAUNDICE
C-GALL was a pragmatic, multicentre, parallel group, patient randomised, superiority trial to test if the strategy of standard, laparoscopic cholecystectomy is more effective and cost effective than conservative management. The trial protocol was published in 2021.We recruited patients from 20 secondary care sites in the UK. Potential participants were adults aged >18 years with confirmed, symptomatic uncomplicated gallstone disease (ie, biliary colic or acute cholecystitis) who were electively referred to secondary care and considered suitable for cholecystectomy. Clinical diagnosis of gallstone disease was confirmed by appropriate imaging. Patients who were unable to consent, medically unfit for surgery, pregnant, or had had previous open major upper abdominal surgery were not eligible for the trial. Also excluded were patients with gallstones in the common bile duct, evidence of previous choledocholithiasis, a history of acute pancreatitis, evidence of obstructive jaundice, evidence of empyema of the gallbladder with sepsis, suspicion of gallbladder cancer, perforated gallbladder (recent or old perforation detected on imaging), or haemolytic disease.