Tzovaras 2012.
Methods | Randomised controlled clinical trial Randomisation ratio: superiority design Interim analysis of the first 100 randomised patients |
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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 |
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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 |
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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 |
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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