Scrutinizing (in)efficient use of cholecystectomy: a randomized trial concerning variation in practice.

Completed

Conditions: Cholelithiasis
gallstone disease
10019818
10017628

Registration Number: NL-OMON45086

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1038

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The percentage of patients pain-free at 12 months of follow-up. Pain free is<br /><br>defined as a visual analogue scale (VAS;<br /><br>validated pain score) less than or equal to 4 over the last four weeks before<br /><br>evaluation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A comparison of usual care with the restrictive strategy on:<br /><br>(a) The proportion of patients being pain-free after cholecystectomy<br /><br>(b) The proportion of cholecystectomies<br /><br>(c) The proportion of patients with complications (i.e. choledocholithiasis,<br /><br>acute cholecystitis, biliary pancreatitis or cholangitis) due to gallstones.<br /><br>(d) Changes in health status and valuation over time. Health status will be<br /><br>measured using generic and disease specific health status questionnaires after<br /><br>informed consent and after 3, 6 and 12 months.<br /><br>(e) Time to pain free<br /><br>(f) The relation between the patients* symptoms and treatment and work<br /><br>performance<br /><br>(g) Cost-effectiveness<br /><br>(h) The proportion of complications due to the cholecystectomy.<br /><br>(i) Patient satisfaction on result of treatment<br /><br>(j) Alternative diagnostic test and treatment (additional to or replacing<br /><br>cholecystectomy)</p><br>