Stain 1991.
Methods | Randomised clinical trial of pts found to have CBDS on ERCP and fit to undergo surgery, randomised to either ERCP/ES + surgery or surgery "alone" . Single centre. All pts suspected of having CBDS (bilirubin > 2 mg/dl, raised amylase, USS evidence of CBDS) underwent ERCP. Follow‐up: exclusions not listed. Drop‐outs not listed. Sample size calculations: no. No power analysis stated. |
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Participants | Los Angeles. USA
52 pts completed the study. Commencement and completion dates not stated. Inclusion criteria: Intact gallbladder, gallstones on USS, CBDS proven on ERC. Exclusion criteria: None stated. Essential investigations: USS, serum biochemistry, ERC, IOC, T‐tube cholangiogram in all having CBDE. |
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Interventions | Group 1:
ERCP followed by ES and stone extraction by basket or spontaneous passage. Subsequent OC +/‐ CBDE in all cases. Surgery scheduled electively.
CBDE performed on basis of ERCP findings and IOC. Group 2: ERCP followed by OC scheduled electively. CBDE performed as necessary. |
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Outcomes | Mortality, morbidity, stone clearance rate, retained stones after surgery, operation time, hospital stay. | |
Notes | Pts in both groups had ERC, therefore surgery arm had complications of ERC. Low ERCP/ES stone clearance rate (65%). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
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 missing data. |
For‐profit bias | Low risk | Appears free of for‐profit support. |
Other bias | Low risk | None. |