Sahoo 2014.
Methods | Parallel randomised controlled clinical trial Randomisation ratio: superiority design |
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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 |
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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. |
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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 |
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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 |