Rhodes 1998.
Methods | Randomised clinical trial comparing LC and lap stone extraction versus LC and postoperative ERCP/ES and endoscopic stone extraction. No protocol violations. Pre‐study power analysis apparently conducted, but details not listed. |
|
Participants | Norwich. UK Study commenced August 1995 and completed August 1997. 80 pts found to have stones and randomised. Inclusion criteria: LC for treatment of symptomatic gallstones with CBDS demonstrated on cholangiogram. Exclusion criteria: Pre‐operative ERCP/ES. No informed consent to proceed to randomisation. Exclusions listed: 8 pre‐operative ERCP/ES, 1 emergency OC and ECD 347 had no stones on IOC. Essential investigations: Pre‐operative USS, IOC. |
|
Interventions | Laparoscopic group:
Trans‐cystic stone extraction if CBD < 9 mm diameter.
If failed or CBD ≥ 9 mm, stone extraction performed via choledochotomy, followed by stent or T‐tube insertion.
Postoperative ERCP required for stent removal.
Post‐operative ERCP or open conversion and duct exploration if laparoscopic extraction failed. Endoscopic group: ERCP and ES pre‐operatively. Repeated procedures until ducts clear. Followed by laparoscopic cholecystectomy. |
|
Outcomes | Successful laparoscopic clearance, converted to open surgery, median (range) duration of all procedures, median (range) hospital stay. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear. |
Allocation concealment (selection bias) | Unclear risk | Unclear. |
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. |