Sasako 2008.
| Methods | Method of randomization: "the surgeon contacted the [data center] by telephone to receive a randomly generated assignment" Exclusion after randomization: none Lost to follow‐up: none Method of allocation concealment: "the surgeon contacted the [data center] by telephone to receive a randomly generated assignment" Intention‐to‐treat analysis: yes Description of sample size calculation: reported (expected number: 412) | |
| Participants | Number randomly assigned: 523 (D3 = 260, D2 = 263) Age (mean): 60 years Sex (M/F): 359/164 Inclusion criteria: patients with resectable primary non‐metastatic gastric carcinoma Equivalence of baseline characteristics: age, sex and stage distribution similar for both groups |
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| Interventions | D3 versus D2 lymphadenectomy (during gastrectomy) | |
| Outcomes | Overall survival (D3 vs D2): HR 1.03, 95% CI 0.77 to 1.37 Disease free survival (D3 vs D2): HR 1.08, 95% CI 0.83 to 1.42 Postoperative deaths: 2 (D3), 2 (D2) |
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| Notes | Country: Japan Median follow‐up: 5.7 years |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |