Methods |
RCT prospective |
Participants |
134 participants; 66 ROLL; 68 WGL |
Interventions |
ROLL + SLNB; versus WGL + SLNB; versus SLNB |
Outcomes |
Successful localization; excision; margins; re‐intervention rate |
Notes |
Secondary outcomes: operation time; complications; tumour weight/volume; histopathology; operation time |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random number table |
Allocation concealment (selection bias) |
Unclear risk |
Not reported |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Not blinded, but outcome unlikely to be influenced (acceptable as per surgical design) |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Not blinded, but outcome unlikely to be influenced (acceptable as per surgical design) |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
None (all data reported) |
Selective reporting (reporting bias) |
Low risk |
None (all data reported) |
Other bias |
Unclear risk |
Lack of inter‐observer variability |