Introduction/Background Quality assurance in surgical trials is a key point for interpretation and applicability of results. We wanted to assess this point after one third of inclusions.

Methodology We included patients randomized between 07/06/2018 and 01/01/2022 in SENTICOL III (Arm A: SLN only; Arm B: SLN + PLND). We extracted data concerning inclusion/exclusion criteria, surgical and pathological features and completion of quality-of-life questionnaires.

Results 447 patients were included and 362 were randomized (bilateral SLN detection and negative frozen section; 181 patients in each arm). Almost all patients fulfilled the inclusion criteria in terms of histopathological factors: 52.2% had stage Ib1 and 28.4% stage Ib2 (FIGO 2018); 55.7% were squamous and 35.6% were adenocarcinomas. Diagnosis was based on conization in 53.7%. ICG was the most commonly used tracer (76.4%). SLN detection rate was 94.4%. One SLN (median) was removed from each pelvic sidewall [3 (1–11)]. Three patients had at least one SLN harvested in the paraaortic area. 161/165 patients had a completion lymphadenectomy in Arm B. Minimally invasive surgery was used in 43.7% of patients, robotic in 26.9% and laparotomy in 29.4%. False negative rate was 4% in arm B patients. The median number of pathological levels for SLN evaluation was 4 (0–12). Final pathological analysis showed isolated tumor cells in 6 patients (1.9%), micrometastasis in 8 (2.6%) and macrometastasis in 3 (1%). False negative rate of frozen section was 5.5%. Quality of life questionnaires were available at baseline in 93.6% and 86.5% at 36 months.

Conclusion This analysis showed that quality assurance was respected in this trial. The rate of minimally invasive surgery was higher than expected. The next time points are the interim analysis (after 45 DFS events), end of inclusions in Q2 2024 and final results in 2029.

Disclosures No disclosure.