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

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
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)
Notes Country: Japan
Median follow‐up: 5.7 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 Low risk