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599 Modified minimally invasive versus open radical hysterectomy in early-stage cervical cancer: interim analysis of a multicenter, prospective, randomized controlled clinical trial
  1. Tao Zhu1,
  2. Yang Shen2,
  3. Zhen Shen3,
  4. Xi Chen1,
  5. Bo Ding2,
  6. Yin Zhou3,
  7. Tianjiao Zhang3,
  8. Chenyan Fang1,
  9. Yingli Zhang1,
  10. Min Li3,
  11. Lu Chen1,
  12. Zhuyan Shao1,
  13. Wen Gao1,
  14. Yuxin Zhu2,
  15. Jingyun Xu2,
  16. Xin lv2,
  17. Jing Zhu3 and
  18. Yuebo Li3
  1. 1Zhejiang Cancer Hospital, Hangzhou, China
  2. 2The Afliated Zhongda Hospital, Southeast University, Nanjing, China
  3. 3The First Affiliated Hospital of USTC, Hefei, China

Abstract

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.

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