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

Morino 2006.

Methods Parallel randomised controlled clinical trial
Randomisation ratio: superiority design
Participants 91 elective patients with cholelithiasis and common bile duct stones diagnosed at MRCP; mean age 59.5 years; male 38.4%; normal value of total bilirubin: 72.5%; normal value of gamma GT: 92%; normal value of AST: 80.15%; normal value of amylase: 26%; common bile duct diameter ⋝10 mm: 62.6%
Inclusion criteria: people with gallbladder and main bile duct stones
Exclusion criteria: acute cholangitis, necrotizing pancreatitis, age < 18 years, ASA status IV and V
Diagnostic criteria: gallbladder and main bile duct stones were detected by transabdominal ultrasound and MRCP
Interventions Number of study centres: one
Treatment before study: not reported
Type of interventions: 46 participants treated in a single step with videolaparoscopic cholecystectomy, intraoperative cholangiography, and endoscopic sphincterotomy during the surgical procedure with the rendezvous technique, and 45 treated with preoperative ERCP and endoscopic sphincterotomy using a traditional method of bile duct cannulation.
Outcomes Morbidity, clinical pancreatitis, hyperamylasaemia, failure rate, mean hospital stay (days)
Notes Run‐in period: from May 2001 to August 2005
Study terminated before regular end (for benefit or because of adverse events): no
Follow‐up: 19 to 20 months
Funding sources: no information reported
Declaration of interest: no information reported
Country: Italy
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Sealed opaque 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 outcome assessors were blinded to the treatments or not.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk None
Selective reporting (reporting bias) Unclear risk The study protocol was not available.
Other bias High risk The learning curve was not reported.
for‐profit bias Unclear risk Information about sponsorship or trial support not reported