Fast Track Pathway to Accelerated Cholecystectomy (FAST)
Cholecystitis, Cholecystectomy
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring cholecystitis, cholecystectomy, accelerated surgery, feasibility study
Eligibility Criteria
Inclusion Criteria:
- Age ≥45 years; or age ≥18 years and <45 years with at least one of the following co-morbidities: diabetes or chronic respiratory, cardiovascular, or renal disease;
Diagnosis of acute cholecystitis defined by the presence of at least 2 of the following:
- Abdominal pain in upper right quadrant,
- Murphy's sign,
- Leukocytosis >10 × 103/μl, or
- Oral temperature <36.5°C or >38°C;
- Cholelithiasis (stones/sludge);
- Ultrasound signs of cholecystitis;
- Acute cholecystitis that requires surgery and is diagnosed during working hours;
- Expected to require at least an overnight hospital admission after surgery; and
- Provide written informed consent to participate in FAST.
Exclusion Criteria
- Patients requiring emergent surgery or emergent interventions for another reason;
- Patients whose therapeutic anticoagulation is not reversible;
- Patients with a history of heparin-induced thrombocytopenia and current use of warfarin with an INR ≥1.5;
- Pregnant patients;
- Previous participation in the trial.
Sites / Locations
- Hamilton General Hospital
- Juravinski Hospital
- St. Joseph's Healthcare
- Lawson Health Research Institute, London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard of Care
FAST Intervention
Patients randomized to the standard of care arm of the trial will not receive accelerated cholecystectomy surgery to correct cholecystitis. No services will be taken away but patients will continue with care as originally provided by the healthcare system.
Patients diagnosed with cholecystitis and randomized to the FAST intervention arm of the study will undergo surgery as soon as possible with a goal of surgery within 6 hours of diagnosis.