599 Modified minimally invasive versus open radical hysterectomy in early-stage cervical cancer: interim analysis of a multicenter, prospective, randomized controlled clinical trial

Introduction/Background To assess the feasibility and safety of the modified minimally invasive radical hysterectomy (intra-abdominal colpotomy and Uterine suspension) in cervical cancer patients with stage IA1-IB2 tumors ≤2 cm. Methodology We performed a prospective, randomized controlled, multicenter study of patients with cervical cancer between January 2020 to March 2023 at three cancer centers from Yangtze River Delta region in China.Key eligibility criteria included:(1) FIGO 2019 stage IA1 (with lymphovascular space invasion), IA2-IB1 Cervical Cancer; (2) squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma;(3) tumor size ≤2 cm (MRI evaluation or pathological evaluation after cervical conization); (4) negative imaging of metastatic disease. Results Of the 113 evaluable patients enrolled, 60 (53%) underwent modified minimally invasive surgery. Median follow-up was 12.0 months (95%CI, 9.8–14.5) in the modified minimally invasive group and 7.5 months (95%CI, 7.8–12.1) in the open group.Clinicopathological patient characteristics were well balanced between the two groups, in terms of age, BMI, pathological type, histological grade, and pathological stage.Among the 113 patients enrolled, 32 (28.3%) were stage IA, and 81 (71.7%) were stage IB1. 5(4.4%) patients had tumor size >2 cm. 4(3.5%)patients had lymph node metastasis. None developed recurrent disease within 1 year regardless of the surgical approach. The amount of intraoperative blood loss in laparoscopic surgery was significantly less than that of conventional surgery(p=0.012). The laparoscopic surgery group(195.84±44.67min) had a significantly longer operation time than conventional surgery(170.65 ±35.96min) (p=0.001). The incidence of adverse events in the laparoscopic surgery group was 41.7%, which was significantly lower than that in the traditional surgery group (p=0.046). There were no serious adverse effects in either group. Conclusion The promising interim analysis of this prospective data demonstrate that modified minimally invasive radical hysterectomy(intra-abdominal concealed colpotomy and uterine suspension ) is feasible and safe for patients with selected cervical carcinoma, but we need to wait for the final analysis to confirm. Disclosures No financial disclosures.