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Scrutinizing the (in)efficient use of cholecystectomy.


- candidate number14957
- NTR NumberNTR4022
- ISRCTNISRCT wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jun-2013
- Secondary IDsMETC 2013_129 SECURE-trial
- Public TitleScrutinizing the (in)efficient use of cholecystectomy.
- Scientific TitleScrutinizing the (in)efficient use of cholecystectomy: a randomized trial concerning variation in practice
- ACRONYMSECURE
- hypothesisStepwise 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 patientsí health status, prevent complications, reduce health care demand and lower costs.
- Healt Condition(s) or Problem(s) studiedCholecystectomy, Randomised study, Randomized controlled trial, gall stones
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2013
- planned closingdate1-aug-2015
- Target number of participants986
- InterventionsThe 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.
- Primary outcomeThe 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 outcome1. 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 patientsí 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.
- TimepointsFollow-up at 3,6,9 and 12 months after initial presentation.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES A.H. Dijk, van
- CONTACT for SCIENTIFIC QUERIES A.H. Dijk, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD5-jun-2013 - 20-jun-2013


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