Robotic-assisted versus conventional laparoscopic surgery for endometrial cancer: Long-term results of a randomized controlled trial.

Background: Robotic-assisted laparoscopic surgery (RALS) has become a widely and increasingly used modality of minimally invasive surgery in the treatment of endometrial cancer (EC). Due to its technical advantages, RALS offers benefits, such as a lower rate of conversions compared to conventional laparoscopy (CLS). Yet, data on long-term oncological outcomes after RALS is scarce and based on retrospective cohort studies only.

Objectives: This study aimed to assess overall survival (OS), progression-free survival (PFS), and long-term surgical complications in EC patients randomly assigned to RALS or CLS.

Study design: This randomized controlled trial was conducted at the Department of Gynecology and Obstetrics of Tampere University Hospital, Finland. Between 2010 and 2013, 101 patients with low-grade EC scheduled for minimally invasive surgery were randomized preoperatively 1:1 either to RALS or CLS. All patients underwent laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy. A total of 97 patients (49 in the RALS group and 48 in the CLS group) were followed up for a minimum of 10 years. Survival was analyzed using Kaplan-Meier curves, log-rank test, and Cox proportional hazard models. Binary logistic regression analysis was used to analyze risk factors for trocar site hernia.

Results: In the multivariable regression analysis, OS was favorable in the RALS group (HR 0.39; 95% CI, 0.15-0.99, p=.047) compared to the CLS group. There was no difference in PFS (log-rank test, p=.598). The three-, 5- and 10-year OS were 98.0% (95% CI, 94.0-100) vs. 97.9% (93.8-100), 91.8% (84.2-99.4) vs. 93.7% (86.8-100), and 75.5% (64.5-87.5) vs. 85.4% (75.4-95.4) in the CLS and the RALS group, respectively. Trocar site hernia developed more often in the RALS group compared to the CLS group 18.2% vs. 4.1% (OR 5.42, 95% CI, 1.11-26.59, p=.028). The incidence of lymphocele, lymphedema, or other long-term complications did not differ between the groups.

Conclusions: The results of this RCT suggest a minor OS benefit in EC after RALS compared to CLS. Hence, the use of RALS in the treatment of EC seems safe, but larger RCTs are needed to confirm the potential survival benefit of RALS. No alarming safety signals were detected in the RALS group since the rate of long-term complications differed only in the incidence of trocar site hernia.