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. 2015 Aug 12;2015(8):CD001964. doi: 10.1002/14651858.CD001964.pub4

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
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)
Notes Country: Netherlands
Median follow‐up: 15.2 years
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.