A randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of laparoscopic cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-GALL)

 

Summary

Gallstone disease (cholelithiasis) is one of the most common gastrointestinal disorders in industrialised societies. The prevalence of gallstones in adult populations is approximately 10 to 15%. Gallstones are more common in women and people over the age of 40.

Clinical surveys conducted in Europe, North and South America, and Asia indicate that the prevalence rates for gallstone disease range from 5.9% to 25% and tend to increase with age. A clinical ultrasound survey conducted in the UK reported prevalence rates of 12% among men and 22% among women over 60 years of age. A multicentre population-based study conducted in Italy has reported a cumulative incidence of gallstone disease of 0.67% per year (0.66% in men and 0.81% in women).

Natural history studies have shown low mortality from gallstone disease with typically less than 1% of people dying from gallbladder-related causes. In a recent population-based study the overall frequency of symptom development in asymptomatic people was around 20% over a long follow-up period (mean: 8.7 years).

In people with symptomatic gallstone disease, the annual rates of developing complications have been reported to be as low as 1 to 3%. The Italian Group for the Epidemiology and Prevention of Cholelithiasis (GREPCO) study reported an annual incidence of complications of 0.7% for symptomatic people.

In the UK and in North America, the number of surgical procedures for gallstone disease increased steadily between the 1950s and 1990s, reflecting both the rise in prevalence of gallstone disease and the use of cholecystectomy as the treatment of choice. Rates of surgical procedures stabilised in both countries towards the end of the twentieth century.

C-Gall study website

Contact

Karen Innes; kareninnes@abdn.ac.uk  

Status

Data Collection - Recruitment