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

Sahoo 2014.

Methods Parallel randomised controlled clinical trial
Randomisation ratio: superiority design
Participants 83 patients with a diagnosis of cholecysto‐choledocholithiasis; mean age 47.95 years; male 36.1%; mean total serum bilirubin: 7.2 mg/dl; mean serum alkaline phosphatase: 619 IU/L; mean common bile duct diameter: 12.6 mm
Inclusion criteria: people with diagnosis of cholelithiasis and choledocholithiasis
Exclusion criteria: persons with stones in CBD > 12 mm, after undergoing laparoscopic CBD exploration
Diagnostic criteria: abdominal ultrasound and MRCP
Interventions Number of study centres: one
Treatment before study: not reported
Type of interventions: 42 participants treated in a single step with video laparoscopic cholecystectomy, intraoperative cholangiography, and endoscopic sphincterotomy during the surgical procedure with the rendezvous technique versus 41 treated with preoperative ERCP and endoscopic sphincterotomy.
Outcomes Success rate of CBD clearance, incidence of multiple endoscopic procedures within 30 days of the procedure, incidence of hyperamylasaemia within 48 hours post‐ERCP, incidence of severe pancreatitis within 48 hours post‐ERCP, post‐operative hospital stay, number of deaths within 30 days of intervention, patient satisfaction concerning the surgical procedure carried out, endoscopic surgeon's satisfaction with the endoscopic procedure
Notes Run‐in period: from 2005 to 2012
Study terminated before regular end (for benefit or because of adverse events): no
Follow‐up: not reported
Funding sources: none
Declaration of interest: none declared
Country: India
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 outcomes assessors were blinded to the treatments or not.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk None
Selective reporting (reporting bias) High risk The study protocol was not available. Mortality not reported in the results, though it was declared as an outcome in the method section.
Other bias High risk The learning curve was not reported.
for‐profit bias Low risk Free of industry sponsorship or other for‐profit support