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. 2015 Feb 26;2015(2):CD010339. doi: 10.1002/14651858.CD010339.pub2

Montariol 1998.

Study characteristics
Patient sampling Type of study: prospective study.
 Consecutive or random sample: consecutive participants.
Patient characteristics and setting Sample size: 240.
Females: 171 (71.3%).
Age: 57 years.
Presentation:
Inclusion criteria:
  1. People with symptomatic cholelithiasis, scheduled for elective cholecystectomy or emergency operations within 48 hours for acute cholecystitis.


Exclusion criteria:
  1. Cholelithiasis was asymptomatic.

  2. Preoperative risk of common bile duct stones < 5%

  3. People had symptomatic choledocholithiasis defined as combination of clinical symptoms (pancreatic pain and jaundice), biochemical abnormalities (serum aminotransferase, alkaline phosphatase or γ‐glutamyl transpeptidase levels more than twice normal values, serum bilirubin levels > 50 µmol/L, serum amylase level > 4‐fold, and serum lipase levels > 3‐fold), and morphological features (presence of hyperechoic image in the common bile duct on ultrasonography.


Setting: Surgery Departments, France.
Index tests Index test: intraoperative cholangiography.
 Further details:
 Technical specifications: not applicable.
 Performed by: surgeon.
 Criteria for positive diagnosis: not stated.
Target condition and reference standard(s) Target condition: common bile duct stones.
 Reference standard: surgical extraction of stones in people with positive intraoperative cholangiography and clinical follow‐up of minimum 12 months in people with negative intraoperative cholangiography.
 Further details:
 Technical specifications: not applicable.
 Performed by: surgeons and clinicians.
 Criteria for positive diagnosis: surgical extraction of stones in people with positive intraoperative cholangiography and clinical follow‐up of minimum 12 months in people with negative intraoperative cholangiography.
Flow and timing Number of indeterminates for whom the results of reference standard was available: not stated.
 Number of participants who were excluded from the analysis: 25 (10.4%).
Comparative  
Notes Attempted to contact the authors in June 2013. Received replies in July 2013.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
    Low Low
DOMAIN 2: Index Test IOC
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
    Low High
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? No    
    High High
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? No    
Were all patients included in the analysis? No    
    High