Songun 2010.
| Methods | Method of randomization: "The sequence of randomisation was in blocks of six with stratification according to the participating centre." Exclusion after randomization: D1 = 133 (metastatic disease); D2 = 152 (metastatic disease) Lost to follow‐up: one Method of allocation concealment: "The sequence of randomisation was in blocks of six with stratification according to the participating centre." Intention‐to‐treat analysis: yes Description of sample size calculation: reported (expected number: 1062) | |
| Participants | Number randomly assigned: 523 (D2 = 483, D1 = 513) Age < 70 years: 33% Sex (M/F): 401/310 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 | D2 versus D1 lymphadenectomy (during gastrectomy) | |
| Outcomes | Overall survival (D2 vs D1): HR 0.92, 95% CI 0.78 to 1.09 Disease specific survival (D2 vs D1): HR 0.74, 95% CI 0.59 to 0.93 Disease free survival (D2 vs D1): HR 0.95, 95% CI 0.82 to 1.10 Postoperative deaths: 32 (D2), 15 (D1) |
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| Notes | Country: Netherlands Median follow‐up: 15.2 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 | Unclear risk | It is unclear whether the number of patients excluded after randomization had any impact on the trial outcomes. |