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. 2018 Apr 11;2018(4):CD010507. doi: 10.1002/14651858.CD010507.pub2

Tzovaras 2012.

Methods Randomised controlled clinical trial
Randomisation ratio: superiority design
Interim analysis of the first 100 randomised patients
Participants 100 patients with cholecysto‐choledocholithiasis; one patients from the control group withdrew consent after randomisation; mean age: 67.5 years; male: 46.5%; median common bile duct diameter: 9 mm; mean BMI: 27; ASA I: 51.5%, II: 37.5%, III: 11%
Inclusion criteria: people with stones in gallbladder and CBD
Exclusion criteria: age < 18 years, ASA status IV and V, BMI > 35, previous ERCP attempt, history of upper abdominal surgery, and pregnancy
Diagnostic criteria: gallbladder and main bile duct stones were detected by both transabdominal ultrasound and MRCP
Interventions Number of study centres: one
Treatment before study: not reported
Type of interventions: 50 patients treated in a single step with videolaparoscopic cholecystectomy, intraoperative cholangiography, and endoscopic sphincterotomy during the surgical procedure with the rendezvous technique versus 49 treated with preoperative ERCP and endoscopic sphincterotomy using a traditional method of bile duct cannulation
Outcomes Mortality, morbidity, conversions, clinical pancreatitis, serum amylase, failure rate, hospital stay (days)
Notes Run‐in period: from September 2006 to April 2009
Study terminated before regular end (for benefit or because of adverse events): no
Follow‐up: not reported
Funding sources: no information reported
Declaration of interest: none declared
Country: Greece
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization created by a computer‐generated list in blocks of 20 patients.
Allocation concealment (selection bias) Low risk Sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not clearly stated whether the outcomes assessors were blinded to the treatments or not.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk One patient from the control group withdrew consent after randomisation.
Selective reporting (reporting bias) Low risk The trial was registered at one of the available official sites for clinical trials registration (ClinicalTrials.gov ID: NCT00416234).
Other bias Low risk Interim analysis planned after completion of the first 100 patients
for‐profit bias Unclear risk Information about sponsorship or trial support not reported

ERCP = endoscopic retrograde cholangiopancreatography; LERV = laparoscopic‐endoscopic rendezvous; CBD = common bile duct; MRCP = magnetic resonance cholangiopancreatography; ASA = American Society of Anesthesiologists; BMI = body mass index; AST = aspartate aminotransferase