Introduction/Background With an effective of reducing tumor cells dissemination, non-touch isolation techniques are being emphasized during operation these days. Compared with total abdominal radical hysterectomy, whether improving the tumor-free strategy in the laparoscopic/robotic radical hysterectomy (minimally invasive surgery) benefits patients, is still unclear.

Methodology Patients with early-stage cervical cancer (stage IA1 with lymphovascular invasion, IA2, IB1, IB2 and IIA1) were prospectively enrolled in this study, and were divided into two groups of minimally invasive group (MIS group) and abdominal group according to received surgery. The MIS group forbade traditional uterine manipulators, and improved vaginal closure procedure by using ligature and suture. The primary outcome was disease-free survival (DFS) at 5 years, with noninferiority declared if the lower limit of the unilateral 97.5% confidence interval (CI) of the inter-group difference was ≥-5%. Survival analysis was based on Kaplan-Meier method.

Results A total of 947 patients were included in the abdominal group and 1119 in the MIS group. Patients with stage IB1 were of the highest proportion (45.5%). The two groups were comparable in regard to stage of disease, histological subtype, rates of lymphovascular invasion, parametrial infiltration and lymph-node metastasis. The rate of DFS as of the interim analysis was 97.4% in the MIS group and 96.5% in the abdominal group, with a difference of 0.92% (95% CI, -0.59% to 2.43%). The MIS group showed higher DFS at 2 years than the abdominal group (97.9% vs. 95.5%; hazard ratio, 0.58; 95% CI, 0.34 to 0.97). However, OS at 2 years was nonsignificant between the groups (99.3% vs. 98.7%; hazard ratio, 0.72; 95% CI, 0.27 to 1.91).

Conclusion As of the interim analysis, the MIS group had higher DFS than the abdominal group among patients with early-stage cervical cancer, with a definite noninferiority.

Disclosures All authors declare no conflict of interest.