No registrations found.
ID
Source
Brief title
Health condition
Cholecystectomy, gallstones, randomized trial, variation in practice
Cholecystectomie, galstenen, praktijkvariatie, gerandomiseerde studie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
In this prospective study we will examine the effectiveness of usual care with a restrictive care strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with ultrasound proven gallstones and abdominal complaints over a 12 month period.
Study objective
Stepwise selection of patients with cholecystolithiasis for cholecystectomy is not inferior to usual care with respect to the patient reported outcome, but attributes to a more appropriate use of care and provides a basis for a lower number of cholecystectomies performed.This may improve patients’ health status, prevent complications, reduce health care demand and lower costs.
Study design
Follow-up at 3,6,9 and 12 months after initial presentation.
Intervention
The intervention includes a standardized work-up and multistage selection for cholecystectomy. Standardization is done by strict administration of the symptoms associated with symptomatic cholecystolithiasis as reported in the Dutch national guideline Gallstones.24 In addition, the multistage selection includes an interval evaluation after every 3 months.
Kamer G4-144
Academisch Medisch Centrum Amsterdam
Meibergdreef 9
A.H. Dijk, van
Amsterdam 1105 AZ
The Netherlands
a.h.vandijk@amc.nl
Kamer G4-144
Academisch Medisch Centrum Amsterdam
Meibergdreef 9
A.H. Dijk, van
Amsterdam 1105 AZ
The Netherlands
a.h.vandijk@amc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3862 |
| NTR-old | NTR4022 |
| Other | SECURE-trial : METC 2013_129 |
| ISRCTN | ISRCT wordt niet meer aangevraagd. |