Methods |
Prospective multicentred RCT |
Participants |
305 participants; 152 (intervention), 153 (control), 18 crossover |
Interventions |
RSL (intervention) versus WGL (control) |
Outcomes |
Successful localization; excision; margins; re‐intervention rate |
Notes |
Secondary outcomes: operation time; complications; patient preference |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Centralized stratified |
Allocation concealment (selection bias) |
Low risk |
Concealed |
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 |
Not reported |
Selective reporting (reporting bias) |
Low risk |
Fifteen RSL and 13 WGL participants were withdrawn post‐randomization; 18 received WGL though random to RSL |
Other bias |
Low risk |
Not reported |