Bansal 2010.
Methods | Randomised trial. LC + CBDE vs pre‐operative ERCP +LC. Drop‐outs or protocol violations reported. Sample size calculation: no. |
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Participants | All India Institute of Medical Sciences, India. July 2007 to April 2008. Mean age: Group I: 47.1 yrs vs Group II 39.07 yrs. Pre‐operative confirmation of CBD stones: EUS or MRCP. CBD more than 10 mm size. |
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Interventions | Gr I: LC + LCBDE (15 pts). Gr II: pre‐operative ERCP + LC 4 ‐ 6 weeks later (15 pts). |
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Outcomes | CBD clearance, bleeding, bile leak, pancreatitis, average hospital stay, pain scores (VAS). | |
Notes | Choledochoscopy performed. T‐tube placed after lap CBD exploration. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number sequences. |
Allocation concealment (selection bias) | Low risk | Concealed envelopes with block randomisation design. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible. |
Selective reporting (reporting bias) | Low risk | All outcomes were clearly defined and reported. |
Incomplete outcome data | High risk | Missing pts were not accounted. |
For‐profit bias | Low risk | None. |
Other bias | Low risk | None. |