Hammarstrom 1995.
Methods | Randomised clinical trial comparing ERCP/ES and stone removal versus open surgery alone for pts found to have CBDS proven on ERCP, intravenous cholangiogram, or USS, with an intact gallbladder.
Drop‐outs: 3 (all in surgery arm); 2 refused operation, 1 missing set of notes. Follow‐up: Median 92 (63 to 113) months Group 1, 82 (60 to 113) months Group 2. Sample size calculations: no. |
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Participants | Trial from Sweden. Commenced Sept 1984, completed Jan 1989, but with 5‐year follow‐up data. 83 pts randomised. Inclusion criteria: CBDS found either on ERC, USS or IVC, intact gallbladder, age < 85 yrs (arbitrary), informed consent. Exclusion criteria: Previous B2 anastomosis, malignancy, perforated cholecystitis, unfit for surgery. |
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Interventions | Group 1 (ERCP/ES):
Proceeded to ES and stone extraction by a variety of means (basket, balloon, mechanical lithotriptor). Subsequent surgery only if ongoing biliary symptoms. Group 2 (Surgery): Open cholecystectomy and ECBD on next available list. T‐tube always used. Choledochoscopy optional. |
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Outcomes | Successful stone clearance, additional endoscopic procedures, median hospital stay, complications ‐ bile leak, gastric retention, duodenal injury after surgery, biliary colic (no surgery), pancreatitis (no surgery), re‐operation for bleeding, bile duct injuries, late complications: incisional hernia, retained stone. | |
Notes | Surgery arm all had ERCP to diagnose CBD stones. Unclear if surgery for late symptoms was included in complication assessment. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random 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 | Unclear risk | No missing data. |
For‐profit bias | Low risk | Appears free of for‐profit support. |
Other bias | Low risk | None. |