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ISRCTN
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ISRCTN67485658
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ClinicalTrials.gov identifier
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Public title
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Randomised blind single centre study on morbidity and cost-effectiveness of two types of surgery for cholecystectomy
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Scientific title
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Acronym
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SILAP (Small-Incision versus LAParoscopy)
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Serial number at source
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Protocol 0031
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Study hypothesis
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1. No difference in complications between small-incision and laparoscopic cholecystectomy
2. Difference of 10% in direct costs
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Symptomatic cholecystolithiasis
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Participants - inclusion criteria
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1. Patients with symptomatic cholecystolithiasis
2. Older than 18 years
3. Reasonable to good health as classified by the American Society of Anesthesiologists (ASA) grade I - II
4. Knowledge of the Dutch language
5. Signed informed consent
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Participants - exclusion criteria
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1. Choledocholithiasis
2. Cholangitis
3. Acute cholecystitis
4. Known pregnancy
5. Moderate to severe systemic disease (ASA III or higher)
6. Previous upper abdominal surgery (which would exclude the patient from laparoscopic cholecystectomy)
7. Psychiatric disease
8. History of abdominal malignancy
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Anticipated start date
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01/01/2001
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Anticipated end date
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01/04/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Two groups of 120 patients
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Interventions
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Small-incision versus laparoscopic cholecystectomy
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Primary outcome measure(s)
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1. Mortality
2. Complications
3. Costs
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Secondary outcome measure(s)
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1. Pulmonary function
2. Health-related quality of life
3. Convalescence (return to work)
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Sources of funding
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1. Foundation 'Gasthuisraad' (The Netherlands)
2. Foundation for Scientific Research 'Midden-Brabant' (The Netherlands)
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Trial website
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Publications
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Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/18427025
2. http://www.ncbi.nlm.nih.gov/pubmed/18071815
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Contact name
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Dr
Cees
van Laarhoven
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Address
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Department of Surgery
St Elisabeth Hospital
Hilvarenbeekseweg 60
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City/town
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Tilburg
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Zip/Postcode
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5022GC
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Country
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Netherlands
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Sponsor
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St Elisabeth Hospital (The Netherlands)
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Address
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Department of Surgery
Hilvarenbeekseweg 60
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City/town
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Tilburg
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Zip/Postcode
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5022GC
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Country
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Netherlands
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Sponsor website:
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http://www.elisabeth.nl/
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Date applied
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12/09/2005
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Last edited
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13/06/2008
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Date ISRCTN assigned
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26/01/2006
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