This NIHR HTA evidence synthesis assessed the clinical and cost effectiveness of cholecystectomy compared with observation/conservative management in patients with uncomplicated symptomatic gallstones (biliary colic or cholecystitis). Two good quality RCTs conducted in Norway and involving 201 participants were included in the assessment. The results showed that 88% of people initially randomised to surgery and 45% of people initially randomised to observation eventually underwent cholecystectomy during the 14-year follow-up period.
Participants randomised to surgery experienced more surgery-related complications and showed a slight, non significant, increase in the rate of all-cause mortality than those who were treated conservatively. In contrast, participants allocated to observation had more episodes of cholecystitis, but few other gallstone-related complications (e.g. common bile duct stones, acute pancreatitis). Fifty five percent of people randomised to observation did not require surgery during the long term follow-up and 12% of people randomised to cholecystectomy did not undergo the scheduled operation. The results of the economic evaluation showed that, on average, the surgery strategy was more costly but more effective than the conservative management strategy. There was, however, uncertainty around some parameters used in the model. Approximately 70,000 cholecystectomies are performed every year in the UK. The results of this assessment suggest that surgery could probably be avoided in a proportion of people with symptoms but no complications. However, the paucity of the current evidence and the uncertainty about some of the findings of this assessment, clearly indicate that a well-designed, NHS-based, long term RCT is definitely needed.
Miriam Brazzelli; firstname.lastname@example.org
Completed; for further information see: http://www.nets.nihr.ac.uk/projects/hta/121601