Grant: Project Grant

More than 10% of Canadians have gallstones, and about 10% of these individuals will develop related gallbladder inflammation, which is referred to as acute cholecystitis (AC). Patients with AC who do not have their gallbladder surgically removed have up to 65% risk of serious complications that can lead to death. Surgery is the only definitive treatment, but practice varies widely, specially for high-risk sicker and older patients. Commonly, these high-risk patients are offered conservative treatment with a non-surgical approach (usual care), which may include placement of a temporary drain inserted in the gallbladder through the skin and antibiotics. Although preliminary evidence suggests that early surgery for high-risk patients is associated with shorter hospital length of stay, lower risk for complications and costs, many surgeons opt for usual care in high-risk patients, because the evidence of the benefit of early surgery in this population is limited. The limitations of the existing studies include small number of patients, varied definitions of early versus delayed surgery, and an imbalance of risk between study groups. We propose the FASTER study to inform in a large clinical trial if high-risk patients with AC who receive early surgery (i.e., as soon as possible with a goal of surgery within 24-48 hours of diagnosis) have fewer major complications and/or better quality of life compared with those who receive usual care. This vanguard study will determine if it is feasible to recruit a high-risk population for this study. If feasible, the FASTER larger study would be the first one that may change the paradigm to avoid surgery in high-risk patients suffering from AC.