Cholelithiasis gallstone disease
Conditions
Interventions
Patients will be randomized into 2 groups. The first group comprises usual care
with practice variation in performing laparoscopic cholecystectomy. The second
group comprises a restrictive strategy
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Referred to a surgeon with abdominal complaints and who have ultrasound proven gallstones or sludge (proven before or after referral) 2. Patients age 18 years or older 3. Availability of informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of complicated cholecystolithiasis 2. Indication for primary open cholecystectomy 3. Current treatment for malignancy 4. Expected short life span of less than 12 months 5. ASA score 3 or 4 6. Pregnancy 7. Insufficient knowledge of the Dutch language 8. Mentally incompentent 9. Residence in a federal correctional institution 10. Known cirrhosis of the liver 11. Current schizophrenia, memory deficiency, or any other disorder that predispose them to unreliable questionnaire responses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The percentage of patients 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 four weeks before evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| A comparison of usual care with the restrictive strategy on: (a) The proportion of patients being pain-free after cholecystectomy (b) The proportion of cholecystectomies (c) The proportion of patients with complications (i.e. choledocholithiasis, acute cholecystitis, biliary pancreatitis or cholangitis) due to gallstones. (d) 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. (e) Time to pain free (f) The relation between the patients* symptoms and treatment and work performance (g) Cost-effectiveness (h) The proportion of complications due to the cholecystectomy. (i) Patient satisfaction on result of treatment (j) Alternative diagnostic test and treatment (additional to or replacing cholecystectomy) | — |
Countries
Netherlands
Outcome results
None listed