Nathanson 2005.
Methods | Randomised clinical trial.
Randomisation of pts with CBS at laparoscopic cholecystectomy after failed transcystic clearance to laparoscopic choledochotomy or postoperative ERCP. Follow‐up: no drop‐outs reported. Time period not stated. Trial closed prior to reaching original sample size calculations due to slow accrual. |
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Participants | Brisbane. Australia. Commenced June 1998 and completed October 2003. 86 pts randomised. (286 pts had successful laparoscopic transcystic stone clearance from a total of 372 pts). Exclusion criteria: ERCP prior to referral for LC. CBD diameter less than 7 mm at LC or if bilioenteric drainage required at same time. |
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Interventions | 41 pts randomised to laparoscopic choledochotomy with or without biliary drainage with T‐tube or stent. 45 pts randomised to postoperative ERCP during same admission. |
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Outcomes | Mortality, morbidity, bile leak, stone clearance rates, re‐operation rate, hospital stay. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised. |
Allocation concealment (selection bias) | Low risk | Phone call to the trial centre available 24 hours a day. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible. |
Selective reporting (reporting bias) | Low risk | None. |
Incomplete outcome data | Low risk | No significant missing data. |
For‐profit bias | Low risk | Appears free of for‐profit support. |
Other bias | Low risk | None. |