Sgourakis 2002.
Methods | Randomised clinical trial comparing laparoscopic surgery vs pre‐operative ERCP and surgery. Single centre. Study commenced April 1997, completed August 2000. Follow‐up: drop‐outs not reported. Median postoperative 22.36 months (7 to 36). Sample size calculations: no. |
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Participants | Athens, Greece. 78 pts randomised (36 Group A, 42 Group B) with high risk for CDS on USS and/or biochemical criteria. ASA I or II pts. 8 pts excluded because of 'poor performance' status. Further 6 refused consent. |
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Interventions | Laparoscopic group ‐ transcystic and choledochotomy approaches described in detail. In ERCP group ‐ surgery performed usually within 2 days. | |
Outcomes | Primary clearance success, morbidity, mortality, median hospital stay. | |
Notes | 8/36 of surgical arm (Group A) and 10/42 endoscopy arm (Group B) had no CBDS found at the time of the procedure. No explanation given for choice of transcystic or direct CBD approaches in Group A. 1 pt in each group with CBDS in situ at end of trial. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Methods of randomisation were ambiguous. The guidelines of a randomised trial with the probability of samples method and stratified sampling were applied. A preliminary retrospective study was conducted. Authors also mentioned: "Patients were assigned in two groups (LCBDE vs ERCP). All patients had an informed consent for their randomisation. We had to take into account and the preference of the surgeon responsible for their treatment." The author is not contactable at the provided email address. |
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 | Unclear. |
Incomplete outcome data | Low risk | Unclear. |
For‐profit bias | Low risk | Unclear. |
Other bias | Low risk | Unclear. |