Hong 2006.
Methods | Randomised clinical trial. LC + LCBDE vs LC + intra‐operative ERCP. Sample size estimation: No. Follow‐up: not mentioned. |
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Participants | Medical College of Zhejiang University, People's Republic of China
January 2002 to December 2003. LC+CBDE: 141 pts. LC + intra‐operative ERCP: 93 pts. Confirmation: USS/MRCP/IOC. Inclusion criteria: History, examination, USS, MRCP or cholangiogram. USS was positive in 174 pts, MRCP was positive in 3 and 57 had positive intra‐ operative cholangiogram. Exclusion criteria: none mentioned. |
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Interventions | Primary closure of CBD using 3'0 Vicryl in 45 cases and T‐tube placement in 96 cases. A second cholangiogram was performed to ensure an unobstructed CBD stone. |
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Outcomes | Success rates, surgical time, postoperative hospital stay, hospital charges, complications. | |
Notes | ERCP ‐ small stones of 5 ‐ 8mm size were cleared by saline irrigation, larger stones by basket/balloon catheter. Sphincterotomy and lithotriptor were used only for stones larger than 15mm. Transcystic extraction for smaller stones and transcholedochal extraction for larger stones were performed. T‐tube was used in 96 cases and primary closure of CBD was performed in 46 pts. Cholangioscope was used. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised according to their identification numbers. |
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 | All outcomes were clearly defined and reported. |
Incomplete outcome data | Low risk | No missing data |
For‐profit bias | Low risk | Appears free of for‐profit support. |
Other bias | Low risk | None. |