Scrutinizing the (in)efficient use of cholecystectomy.
- Conditions
- Cholecystectomy, gallstones, randomized trial, variation in practiceCholecystectomie, galstenen, praktijkvariatie, gerandomiseerde studie.
- Registration Number
- NL-OMON27558
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 986
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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. The proportion of patients being pain-free after cholecystectomy;<br /><br>2. The proportion of cholecystectomies;<br /><br>3. The proportion of patients with complications (i.e. choledocholithiasis, acute cholecystitis, biliary pancreatitis or cholangitis) due to gallstones;<br /><br>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;<br /><br>5. Time to pain free;<br /> <br>6. The relation between the patients’ symptoms and treatment and work performance as reported in the Health and Labour questionnaire;<br /><br>7. Cost-effectiveness;<br /><br>8. The proportion of complications due to the cholecystectomy.