Methods |
Prospective RCT |
Participants |
100 participants; 50 ROLL; 50 WGL |
Interventions |
ROLL (intervention) versus WGL (control) |
Outcomes |
Successful localization; excision; margins; re‐intervention rate; intraoperative re‐resection |
Notes |
Secondary outcomes: operation time; complications; LOS; cosmesis |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
RCT; at office |
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 |
Selective reporting (reporting bias) |
Low risk |
None |
Other bias |
High risk |
Mixed pathology; no definitions of margins |