Rabago 2006.
Methods | Parallel randomised controlled clinical trial Randomisation ratio: superiority design |
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Participants | 123 patients referred for laparoscopic cholecystectomy; mean age not reported; sex not reported; total bilirubin: intraoperative ERCP: 3.1 mg/dl (SD 2.9), pre‐operative ERCP: 2.0 mg/dl (SD 2.0); GGT: intraoperative ERCP 441 IU (SD 326 IU), pre‐operative ERCP: 334 IU (SD 281 IU) Inclusion criteria: people with intermediate risk of choledocholithiasis; one of the following major screening criteria: recent episode of cholangitis; bilirubin level > 3.5 mg/dl, or ultrasound evidence of a shadowing object within the bile duct; or at least two of the following minor screening criteria: recent episode of acute pancreatitis, cholecystitis or jaundice; elevated liver function tests above the normal limits; or a dilated common bile duct > 8 mm on ultrasound Exclusion criteria: age > 18 years to < 80 years Diagnostic criteria: gallbladder and main bile duct stones were detected by transabdominal ultrasound. Computed tomography or MRCP were optional, and rarely used in either study group. |
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Interventions | Number of study centres: one Treatment before study: not reported Type of interventions: 59 participants treated in a single step with videolaparoscopic cholecystectomy, intraoperative cholangiography, and endoscopic sphincterotomy during the surgical procedure with the rendezvous technique versus 64 treated with preoperative ERCP and endoscopic sphincterotomy performed using a traditional method of bile duct cannulation. |
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Outcomes | Success rate (on an intention‐to‐treat basis), total morbidity (mild to moderate morbidity, severe morbidity), post‐ERCP morbidity (mild to moderate morbidity, severe morbidity), post‐ERCP acute pancreatitis, post‐ERCP cholecystitis, post‐ERCP cholangitis, post‐ERCP papillar bleeding, morbidity of cholecystectomy | |
Notes | Run‐in period: from June 1999 to June 2003 Study terminated before regular end (for benefit or because of adverse events): no Follow‐up: 24 months Funding sources: no information reported Declaration of interest: none declared Country: Spain |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number generator |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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) | 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 |