Excisional treatment in women with cervical adenocarcinoma-in-situ (AIS): a prospective randomised controlled non-inferiority trial to compare AIS persistence/recurrence after loop electrosurgical excision procedure to cold knife cone biopsy.

Our findings suggest that LEEP may be a safe alternative to CKC when performed in a tertiary dysplasia or gynecologic oncology center. LEEP was associated with fewer post-operative complications. A definitive phase 3 randomized non-inferiority trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted. However, given the slow accrual in the current study, and the required sample size to demonstrate non-inferiority of LEEP, a phase 3 trial would not be feasible in Australia and New Zealand and would require international collaboration.