Cholecystectomy, gallstones, randomized trial, variation in practice Cholecystectomie, galstenen, praktijkvariatie, gerandomiseerde studie.
Conditions
Interventions
The intervention includes a standardized work-up and multistage selection for cholecystectomy. Standardization is done by strict administration of the symptoms associated with symptomatic cholecystoli
Sponsors
Academisch Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: 1. Having abdominal symptoms and having ultrasound proven gallstones or sludge (proven before or after referral); 2. Being referred to a surgeon for the treatment of suspected symptomatic gallstone disease; 3. Aged 18 years or older; 4. Providing informed consent.
Exclusion criteria
Exclusion criteria: 1. History of complicated cholelithiasis (i.e. choledocholithiasis, acute cholecystitis, biliary pancreatitis or cholangitis) since these types of patients are scheduled for elective cholecystectomy to prevent recurrence of complicated cholelithiasis rather than to prevent complaints of symptomatic cholecystolithiasis; 2. Indication for primary open cholecystectomy; 3. History of current malignancy; 4. Expected short life span of less than 12 months; 5. Suffering from severe or life-threatening systemic diseases (American Society of Anesthesiologists (ASA) class III and IV); 6. Known cirrhosis of the liver; 7. Current schizophrenia, memory deficiency, or any other disorder that predispose them to unreliable questionnaire responses; 8. Mentally incompetent; 9. Insufficient knowledge of the Dutch language; 10. Unable to read due to blindness; 11. Known pregnancy; 12. Residence in a federal correctional institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients being pain free at 12 months of follow-up. Pain free is defined as a visual analogue scale (VAS; validated pain score) less than or equal to 4 over the last two weeks before evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients being pain-free after cholecystectomy; 2. The proportion of cholecystectomies; 3. The proportion of patients with complications (i.e. choledocholithiasis, acute cholecystitis, biliary pancreatitis or cholangitis) due to gallstones; 4. Changes in health status and valuation over time. Health status will be measured using generic and disease specific health status questionnaires after informed consent and after 3, 6 and 12 months; 5. Time to pain free; 6. The relation between the patients’ symptoms and treatment and work performance as reported in the Health and Labour questionnaire; 7. Cost-effectiveness; 8. The proportion of complications due to the cholecystectomy. | — |
Contacts
Public ContactA.H. Dijk, van
Afdeling Chirurgie Kamer G4-144 Academisch Medisch Centrum Amsterdam Meibergdreef 9
Outcome results
None listed