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 |